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ID
13523
Beschreibung
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty
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Versionen (3)
- 04.02.16 04.02.16 -
- 04.02.16 04.02.16 -
- 12.02.16 12.02.16 -
Hochgeladen am
12. Februar 2016
DOI
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Case Report Form Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv
Case Report Form (HIPEC)
- StudyEvent: ODM
Ähnliche Modelle
Case Report Form (HIPEC)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Visit 1: Screening visit and informed consent
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
CRF number
Item
CRF number
integer
C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Visit date
Item
Date of visit
date
C0011008 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Informed consent
Item
Patient received a copy of written and signed informed consent
boolean
C0021430 (UMLS CUI [1])
Informed Consent
Item
Informed Consent for biobanking obtained
boolean
C0021430 (UMLS CUI [1])
Date of informed consent
Item
Date of informed consent for biobanking
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,2])
Year of birth
Item
Year of birth
integer
C2826771 (UMLS CUI [1])
Date ovarian cancer was first diagnosed
Item
Date ovarian cancer was first diagnosed
date
C0029925 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
CL Item
I (0)
CL Item
I-A (1)
CL Item
I-B (2)
CL Item
I-C (3)
CL Item
II (4)
CL Item
II-A (5)
CL Item
II-B (6)
CL Item
III (7)
CL Item
III-A (8)
CL Item
III-A1 (9)
CL Item
III-A1i (10)
CL Item
III-A1ii (11)
CL Item
III-A2 (12)
CL Item
III-B (13)
CL Item
III-C (14)
CL Item
IV (15)
CL Item
IV-A (16)
CL Item
IV-B (17)
Debulking surgery
Item
Has a debulking surgical procedure been performed?
boolean
C1706406 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
Date of debulking procedure
Item
Please give the date the debulking procedure has been performed
date
C0011008 (UMLS CUI [1,1])
C1706406 (UMLS CUI [1,2])
C1706406 (UMLS CUI [1,2])
CL Item
no residue (microscopic) (0)
CL Item
<1cm residual tumor (1)
CL Item
≥1cm residual tumor (2)
Chemotherapy
Item
Did the patient already receive chemotherapy? If yes, please specify below
boolean
C0392920 (UMLS CUI [1])
Chemotherapy
Item
Chemotherapy regimen number
integer
C0392920 (UMLS CUI [1])
Chemotherapeutic agent
Item
Which chemotherapeutic agents have been used?
text
C0729502 (UMLS CUI [1])
CL Item
intravenous (1)
CL Item
intraperitoneally (2)
CL Item
other (3)
Chemotherapy Start Date
Item
Chemotherapy Start Date
date
C0808070 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Chemotherapy End Date
Item
Chemotherapy End Date
date
C0806020 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Chemotherapy currently ongoing
Item
Chemotherapy currently ongoing
boolean
C2827774 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
Other treatment
Item
Did the patient receive any other treatment for the ovarian cancer? If yes please specify below
boolean
C0087111 (UMLS CUI [1])
CL Item
hormone/biological (1)
CL Item
antineoplastic immunotherapy (2)
CL Item
radiotherapy (3)
CL Item
other (4)
Other treatment
Item
Please specify any other treatment, not listed above
text
C0087111 (UMLS CUI [1])
Date of relapse diagnosis
Item
Date of relapse diagnosis
date
C0178760 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
eyes,nose,ears,throat (1)
CL Item
cardiovascular system (2)
CL Item
respiratory tract (3)
CL Item
gastrointestinal system, liver (4)
CL Item
gynaecological incl breasts (5)
CL Item
neurological disorder (6)
CL Item
hematology (7)
CL Item
endocrine system (8)
CL Item
musculoskeletal system (9)
CL Item
skin (10)
CL Item
allergies/hypersensitivities (11)
CL Item
urinary tract (12)
CL Item
other (13)
Diagnosis
Item
Diagnosis or ICD-Code
text
C0011900 (UMLS CUI [1])
Date of onset
Item
Please give the date, the condition was first diagnosed
date
C0574845 (UMLS CUI [1])
End date of illness
Item
Please give the date the condition was cured
date
C0806020 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0221423 (UMLS CUI [1,2])
Persistent illness
Item
Persistent illness
boolean
C0205322 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C0221423 (UMLS CUI [1,2])
Heart rate
Item
Heart rate count
integer
C0018810 (UMLS CUI [1])
Blood pressure
Item
Blood pressure measurement
text
C0005823 (UMLS CUI [1])
Body Weight
Item
Body Weight
float
C0005910 (UMLS CUI [1])
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
BMI
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Body Temperature
Item
Body Temperature
float
C0005903 (UMLS CUI [1])
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
Karnofsky performance status
Item
Karnofsky performance status
integer
C0206065 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
General physical condition
Item
General physical condition:further comment
text
C1142435 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Skin assessment
Item
Skin assessment:further comment
text
C0419929 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Cardiovascular system
Item
Cardiovascular system:further comment
text
C0007226 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Respiratory system
Item
Respiratory System:further comment
text
C0035237 (UMLS CUI [1])
CL Item
none (1)
CL Item
yes (2)
CL Item
not assessed (3)
Otorhinolaryngologic diseases
Item
Otorhinolaryngologic diseases:further comment
text
C0029896 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Abdominal examination
Item
Abdominal examination:further comment
text
C0438120 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Lymphatic system
Item
Lymphatic system:further comment
text
C0024235 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Mucous Membranes
Item
Mucous Membranes:further comment
text
C0026724 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Pathological (2)
CL Item
not assessed (3)
Neurological examination
Item
Neurological examination:further comment
text
C0027853 (UMLS CUI [1])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Gynecological Examination
Item
Gynecological Examination:further comment
text
C0200044 (UMLS CUI [1])
Item
Urinary Tract and Kidney Examination
text
C0042027 (UMLS CUI [1,1])
C0227665 (UMLS CUI [1,2])
C0227665 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
pathological (2)
CL Item
not assessed (3)
Urinary Tract and Kidneys
Item
Urinary Tract and Kidneys:further comment
text
C0042027 (UMLS CUI [1,1])
C0227665 (UMLS CUI [1,2])
C0227665 (UMLS CUI [1,2])
Other Findings
Item
Please specify any other clinically significant findings
text
C0159135 (UMLS CUI [1])
Concomitant Agent
Item
Does the patient currently use any other medication?If yes please specify on the enclosed concomitant medication form
boolean
C2347852 (UMLS CUI [1])
ECG Date
Item
Date ECG was performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
pathological, clinically not significant (please specify below) (2)
CL Item
pathological, clinically significant (please specify below) (3)
ECG findings
Item
Please specify any ECG findings
text
C0438154 (UMLS CUI [1])
Date of venous blood sampling
Item
Date of venous blood sampling
date
C0190979 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Time of laboratory procedure
Item
Time of laboratory procedure (according to laboratory sheet)
time
C0022885 (UMLS CUI [1])
Blood coagulation series Quick test
Item
Quick test result
integer
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
C0086890 (UMLS CUI [1,2])
Blood coagulation series Quick test
Item
Quick test value at normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
C0086890 (UMLS CUI [1,2])
Blood coagulation series Quick test
Item
Are Quick test findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0086890 (UMLS CUI [1,2])
C0086890 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Prothrombin time ratio
integer
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
C0491338 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Prothrombin time ratio within normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
C0491338 (UMLS CUI [1,2])
Blood coagulation series PTT
Item
Are PTT findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0491338 (UMLS CUI [1,2])
C0491338 (UMLS CUI [1,2])
Blood coagulation series INR
Item
INR test result
integer
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
C0851084 (UMLS CUI [1,2])
Blood coagulation series INR
Item
INR test within normal range?
boolean
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
C0851084 (UMLS CUI [1,2])
Blood coagulation series INR
Item
Are INR test findings clinically significant?
boolean
C0005790 (UMLS CUI [1,1])
C0851084 (UMLS CUI [1,2])
C0851084 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Creatinine measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Creatinine value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
Serologic tests Creatinine
Item
Are Creatinine measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
C0201975 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Urea measurement value
integer
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C0523961 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Urea measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C0523961 (UMLS CUI [1,2])
Serologic tests Urea measurement
Item
Are Urea measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])
C0523961 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Bilirubin measurement value
integer
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
C0344395 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Is Bilirubin measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
C0344395 (UMLS CUI [1,2])
Serologic tests Bilirubin measurement
Item
Are Bilirubin measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])
C0344395 (UMLS CUI [1,2])
Serologic tests GPT measurement
Item
GPT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,2])
Serologic tests GPT measurement
Item
Is GPT value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,2])
Serologic measurement GPT measurement
Item
Are GPT measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])
C0201836 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
GOT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
Is GOT value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
Serologic tests GOT measurement
Item
Are GOT measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
Serologic tests GGT measurement
Item
GGT measurement value
integer
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
C0202035 (UMLS CUI [1,2])
Serologic tests GGT Measurement
Item
Is GGT measurement within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
C0202035 (UMLS CUI [1,2])
Serologic tests GGT measurement
Item
Are GGT measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])
C0202035 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Albumin measurement value
integer
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C0201838 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Is Albumin measurement within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C0201838 (UMLS CUI [1,2])
Serologic tests Albumin measurement
Item
Are Albumin measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0201838 (UMLS CUI [1,2])
C0201838 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Serum potassium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Is serum potassium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,2])
Serologic tests serum potassium
Item
Are serum potassium measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Serum sodium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
C0523891 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Is serum sodium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
C0523891 (UMLS CUI [1,2])
Serologic tests serum sodium
Item
Are serum sodium measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])
C0523891 (UMLS CUI [1,2])
Serologic tests serum calcium
Item
Serum calcium measurement value
integer
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
C0728876 (UMLS CUI [1,2])
Serologic tests serum calcium
Item
Is serum calcium measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
C0728876 (UMLS CUI [1,2])
Serologic measurement serum calcium
Item
Are serum calcium measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])
C0728876 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Serum chloride measurement value
integer
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
C1317978 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Is serum chloride measurement value within normal range?
boolean
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
C1317978 (UMLS CUI [1,2])
Serologic tests serum chloride
Item
Are serum chloride measurement findings clinically significant?
boolean
C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])
C1317978 (UMLS CUI [1,2])
Tumor marker measurement
Item
Tumor marker CA125 measurement value
integer
C0474700 (UMLS CUI [1,1])
C0973166 (UMLS CUI [1,2])
C0973166 (UMLS CUI [1,2])
Tumor marker measurement
Item
Is measurement value of tumor marker CA 125 within normal range?
boolean
C0474700 (UMLS CUI [1,1])
C0973166 (UMLS CUI [1,2])
C0973166 (UMLS CUI [1,2])
Tumor marker measurement
Item
Are tumor marker CA 125 findings clinically significant?
boolean
C0474700 (UMLS CUI [1,1])
C0973166 (UMLS CUI [1,2])
C0973166 (UMLS CUI [1,2])
Urine Sample Date
Item
Urine sample date and time
datetime
C0011008 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0200354 (UMLS CUI [1,2])
Item
Urine Sample test results
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
CL Item
normal (1)
CL Item
abnormal, clinically not significant (2)
CL Item
abnormal, clinically significant (3)
Urine sample test results
Item
If urine sample test results are abnormal, please specify
text
C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Hemoglobin measurement value
integer
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Is the hemoglobin measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,2])
Blood cell count: hemoglobin measurement
Item
Are hemoglobin measurement findings clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,2])
Blood cell count hematocrit level
Item
Hematocrit level
integer
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0518014 (UMLS CUI [1,2])
Blood cell count: Hematocrit level
Item
Is the hematocrit level within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0518014 (UMLS CUI [1,2])
Blood cell count: Hematocrit level
Item
Are findings in hematocrit level clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0518014 (UMLS CUI [1,2])
C0518014 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Erythrocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
C0014792 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Is the erythrocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
C0014792 (UMLS CUI [1,2])
Blood cell count: erythrocyte measurement
Item
Are findings in erythrocyte measurement clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0014792 (UMLS CUI [1,2])
C0014792 (UMLS CUI [1,2])
Blood cell count: leukocyte measurement
Item
Leukocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
C0023516 (UMLS CUI [1,2])
Blood cell count: leukocyte measurement
Item
Is the leukocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
C0023516 (UMLS CUI [1,2])
Blood cell count:Leukocyte measurement
Item
Are findings in Leukocyte measurement clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0023516 (UMLS CUI [1,2])
C0023516 (UMLS CUI [1,2])
Blood cell count: Neutrophils count
Item
Absolute neutrophils count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,2])
Blood cell count:neutrophils count
Item
Is the count of neutrophils within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,2])
Blood cell count:neutrophils count
Item
Are findings in neutrophils count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0948762 (UMLS CUI [1,2])
C0948762 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Lymphocyte count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C0200635 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Is the count of lymphocytes within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C0200635 (UMLS CUI [1,2])
Blood cell count:lymphocyte count
Item
Are findings in lymphocyte count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0200635 (UMLS CUI [1,2])
C0200635 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Monocyte measurement value
integer
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
C0750880 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Is the monocyte measurement value within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
C0750880 (UMLS CUI [1,2])
Blood cell count: Monocyte count
Item
Are findings in monocyte count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0750880 (UMLS CUI [1,2])
C0750880 (UMLS CUI [1,2])
Blood cell count: Eosinophils count
Item
Eosinophils measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C0200638 (UMLS CUI [1,2])
Blood cell count: Eosinophils count
Item
Is the eosinophils count within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C0200638 (UMLS CUI [1,2])
Blood cell count: eosinophils count
Item
Are findings in eosinophils count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])
C0200638 (UMLS CUI [1,2])
Blood cell count: Basophil count
Item
Basophil measurement value
integer
C0005771 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C0200641 (UMLS CUI [1,2])
Blood cell count: Basophil count
Item
Is the basophil count within normal range?
boolean
Blood cell count: Basophil count
Item
Are findings in basophil count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0200641 (UMLS CUI [1,2])
C0200641 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Platelets count measurement value
integer
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0032181 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Is the platelets count within normal range?
boolean
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0032181 (UMLS CUI [1,2])
Blood cell count: platelets count
Item
Are findings in platelets count clinically significant?
boolean
C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0032181 (UMLS CUI [1,2])
Pre-existing symptoms
Item
Are there pre-existing symptoms?
boolean
C2347662 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
Item
Pre-existing constipation
text
C2347662 (UMLS CUI [1,1])
C0009806 (UMLS CUI [1,2])
C0009806 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the constipation occur for the first time?
date
C0009806 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing Dyspnea
text
C2347662 (UMLS CUI [1,1])
C0013404 (UMLS CUI [1,2])
C0013404 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the Dyspnea occur for the first time?
date
C0013404 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing fatigue
text
C2347662 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the fatigue occur for the first time?
date
C0015672 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the edema occur for the first time?
date
C0013604 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing Lymphedema
text
C2347662 (UMLS CUI [1,1])
C0024236 (UMLS CUI [1,2])
C0024236 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the lymphedema occur for the first time?
date
C0024236 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing lymphocele
text
C2347662 (UMLS CUI [1,1])
C0024248 (UMLS CUI [1,2])
C0024248 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the lymphocele occur for the first time?
date
C0024248 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing sensory neuropathy
text
C2347662 (UMLS CUI [1,1])
C0151313 (UMLS CUI [1,2])
C0151313 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the sensory neuropathy occur for the first time?
date
C0151313 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing motor neuropathy
text
C2347662 (UMLS CUI [1,1])
C1135343 (UMLS CUI [1,2])
C1135343 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the motor neuropathy occur for the first time?
date
C1135343 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing ascites
text
C2347662 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
C0003962 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the ascites occur for the first time?
date
C0003962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing pleural effusion
text
C2347662 (UMLS CUI [1,1])
C0080032 (UMLS CUI [1,2])
C0080032 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the pleural effusion occur for the first time?
date
C0080032 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the pain occur for the first time?
date
C0030193 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing diarrhea
text
C2347662 (UMLS CUI [1,1])
C0011991 (UMLS CUI [1,2])
C0011991 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the diarrhea occur for the first time?
date
C0011991 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing infection
text
C2347662 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Pre-existing infection
Item
Please specify the kind of pre-existing infection
text
C2347662 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,2])
Symptom onset
Item
When did the infection occur for the first time?
date
C0009450 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing vomiting
text
C2347662 (UMLS CUI [1,1])
C0042963 (UMLS CUI [1,2])
C0042963 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the vomiting occur for the first time?
date
C0042963 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing oliguria and anuria
text
C2347662 (UMLS CUI [1,1])
C0028962 (UMLS CUI [1,2])
C0028962 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Symptom onset
Item
When did the oliguria / anuria occur for the first time?
date
C0028962 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Item
Pre-existing other symptoms
text
C2347662 (UMLS CUI [1,1])
C0029625 (UMLS CUI [1,2])
C0029625 (UMLS CUI [1,2])
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
CL Item
lifethreatening (4)
CL Item
not applicable (5)
Other Symptoms
Item
Please specify other pre-existing symptoms
text
C0029625 (UMLS CUI [1])
Symptom onset
Item
When did the symptom occur for the first time?
date
C0029625 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
Age
Item
Patients must be ≥18 Years to ≤70 Years
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
Written informed consent given
boolean
C0021430 (UMLS CUI [1])
Compliance behavior
Item
Patient is willing and able to comply to study protocol
boolean
C1321605 (UMLS CUI [1])
Ovarian carcinoma relapse
Item
Patients with histologically confirmed or strong suspicion of ovarian carcinoma relapse
boolean
C0029925 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,2])
Treatment free interval after treatment with platinum antineoplastic compounds
Item
Treatment free interval after completion of primary treatment with platinum antineoplastic compounds ≥ 6 months
boolean
C0872291 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C3536920 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,2])
C3536920 (UMLS CUI [1,3])
Ovarian carcinoma
Item
Known history and histologically confirmed diagnosis of ovarian carcinoma. (Initial diagnosis)
boolean
C0029925 (UMLS CUI [1])
Ovarian carcinoma histologic differentiation
Item
Histologic differentiations qualifying for inclusion are:serous papillary adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma
boolean
C0029925 (UMLS CUI [1,1])
C0205614 (UMLS CUI [1,2])
C0205614 (UMLS CUI [1,2])
Karnofsky performance status
Item
Karnofsky performance status must be greater than 70 percent.
boolean
C0206065 (UMLS CUI [1])
Patient must be classified "operable"
Item
Patient must be classified "operable"
boolean
C0205188 (UMLS CUI [1])
Neutrophils
Item
Neutrophils must be ≥ 1,500/μl (equivalent of CTC grade 1)
boolean
C0027950 (UMLS CUI [1])
Platelets
Item
Platelets must be ≥ 100,000/μl (CTC grade 0-1)
boolean
C0005821 (UMLS CUI [1])
Creatinine
Item
Creatinine must be ≤ 1.2 mg/dl
boolean
C0201976 (UMLS CUI [1])
Bilirubin
Item
Bilirubin ≤ 1.5 x upper level of normal (CTC Grade 1)
boolean
C1278039 (UMLS CUI [1])
AST
Item
AST ≤ 2.5 x upper level of normal (CTC Grade 1)
boolean
C0201899 (UMLS CUI [1])
Sensory neuropathy
Item
Sensory neuropathy ≤ CTC Grad 2
boolean
C0151313 (UMLS CUI [1])
INR
Item
PT (INR) ≤ 1.5 (Exception: therapeutic antikoagulation- INR 2-3)
boolean
C0525032 (UMLS CUI [1])
Age
Item
Age younger than 18 years or older than 70 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Informed Consent denied
boolean
C0021430 (UMLS CUI [1])
Informed consent limited
Item
Patient is unable to understand extent, significance or consequences of this trial
boolean
C0021430 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Compliance behavior
Item
Patient is unable to follow protocol requirements
boolean
C1321605 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Allergy or hypersensitivity against trial substance
Item
Allergy or hypersensitivity against trial substance or chemically similar substances like Cisplatin or Carboplatin
boolean
C0020517 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
C0008838 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0079083 (UMLS CUI [2,2])
Study subject participation status
Item
Patient is currently or up to 30 days prior to enrollment participating in another clinical trial that includes the use of a trial substance
boolean
C2348568 (UMLS CUI [1])
Substance use disorder
Item
Known or current alcohol, prescription or illegal drug abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy or breast feeding
Item
Current or planned pregnancy or breast feeding mothers
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
Childbearing potential
Item
Women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Laboratory criteria
Item
Fails to meet eligibility criteria in laboratory results
boolean
C1516637 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C1254595 (UMLS CUI [1,2])
Patient judged "inoperable"
Item
Patient has been judged "inoperable"
boolean
C0205187 (UMLS CUI [1])
Mucinous ovarian carcinoma
Item
Diagnose of mucinous ovarian carcinoma
boolean
C1335167 (UMLS CUI [1])
non-invasive borderline tumor
Item
New diagnose or relapse of a non-invasive borderline tumor
boolean
C0862506 (UMLS CUI [1,1])
C2986496 (UMLS CUI [1,2])
C2986496 (UMLS CUI [1,2])
Irradiation
Item
Therapeutic radiology procedure of abdomen or pelvis
boolean
C1522449 (UMLS CUI [1])
Irradiation
Item
Therapeutic radiology procedure of Chest,Skin or Neck/Head for any malignancy less than 3 years ago
boolean
C1522449 (UMLS CUI [1])
Other acute malignancy
Item
Any other acute malignancy or recurrent disease than the investigated indication
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Infection
Item
Acute infection
boolean
C0009450 (UMLS CUI [1])
Comorbidities
Item
Patients with cardiac,pulmonary,renal,hepatic,metabolic,gastrointestinal,chronic or latent infectious or immunocompromising diseases that pose, at the discretion of the investigator, an intolerable risk to the patient
boolean
C0009488 (UMLS CUI [1])
Risk factor
Item
Any other circumstances that pose,at the descretion of the investigator, an unacceptable risk to the patient.
boolean
C0035648 (UMLS CUI [1])
Kidney failure
Item
Patients with severely impaired renal function
boolean
C0035078 (UMLS CUI [1])
Hearing impairment
Item
Patients with hearing impairment
boolean
C1384666 (UMLS CUI [1])
Epilepsy
Item
Patients with a seizure disorder
boolean
C0014544 (UMLS CUI [1])
Neuropathy or neurotoxicity
Item
Patients with preexisting neuropathy or motoric/sensory neurotoxicity (>CTC grade 2)
boolean
C0442874 (UMLS CUI [1])
C0235032 (UMLS CUI [2])
C0235032 (UMLS CUI [2])
Bone marrow depression
Item
Patients with preexisting bone marrow depression
boolean
C0151773 (UMLS CUI [1])
Dehydration
Item
Patients with dehydration
boolean
C0011175 (UMLS CUI [1])
Inclusion
Item
Patient will be included into this trial
boolean
C1512693 (UMLS CUI [1])
CL Item
informed consent has been withdrawn (1)
CL Item
In-/Exclusion criteria have not been met (2)
CL Item
other (3)
Exclusion
Item
If patient is excluded for other reasons, please specify below
text
C2828389 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])
Signature
Item
Signature by investigator: I personally controlled all entries into this form for this patient. All data and statements in this CRF are complete and correct
text
C1519316 (UMLS CUI [1])
Date
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])