ID

13565

Beschrijving

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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D002945

D017426

C56

16-02-16 16-02-16 -

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16 februari 2016

DOI

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Creative Commons BY-NC 3.0

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Visit 8 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

model
Details

Case Report Form (HIPEC) Visit 8

1 Formulieren

StudyEvent: ODM
1. Case Report Form (HIPEC) Visit 8

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Visit 8: Day 21 post-OP

Item Group

Visit 8: Day 21 post-OP

Patient ID

Item

Patient ID

integer

C1269815 (UMLS CUI [1])

CRF number

Item

CRF number

integer

C1516308 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])

Date

Item

Date of visit

date

C0011008 (UMLS CUI [1])

Vital signs and physical examination

Item Group

Vital signs and physical examination

Heart rate

Item

Heart rate count

integer

C0018810 (UMLS CUI [1])

Blood pressure

Item

Blood pressure measurement

text

C0005823 (UMLS CUI [1])

Body Temperature

Item

Body Temperature

float

C0005903 (UMLS CUI [1])

ECOG

Item

Performance status (ECOG):

text

C1520224 (UMLS CUI [1])

ECOG

Code List

Performance status (ECOG):

CL Item

0 (0)

CL Item

1 (1)

CL Item

2 (2)

CL Item

3 (3)

CL Item

4 (4)

CL Item

5 (5)

General physical condition

Item

General physical condition

text

C1142435 (UMLS CUI [1])

General physical condition

Code List

General physical condition

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])

Skin assessment

Item

Skin assessment

text

C0419929 (UMLS CUI [1])

Skin assessment

Code List

Skin assessment

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])

Cardiovascular system

Item

Cardiovascular system assessment

text

C0007226 (UMLS CUI [1])

Cardiovascular system

Code List

Cardiovascular system assessment

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])

Respiratory system

Item

Respiratory system assessment

text

C0035237 (UMLS CUI [1])

Respiratory system

Code List

Respiratory system assessment

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])

Otorhinolaryngologic diseases

Item

Otorhinolaryngologic diseases

text

C0029896 (UMLS CUI [1])

Otorhinolaryngologic diseases

Code List

Otorhinolaryngologic diseases

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])

Abdominal examination

Item

Abdominal examination

text

C0438120 (UMLS CUI [1])

Abdominal examination

Code List

Abdominal examination

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])

Lymphatic system

Item

Lymphatic system

text

C0024235 (UMLS CUI [1])

Lymphatic system

Code List

Lymphatic system

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])

Mucous Membranes

Item

Mucous Membranes

text

C0026724 (UMLS CUI [1])

Mucous Membranes

Code List

Mucous Membranes

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])

Neurological examination

Item

Neurological examination

text

C0027853 (UMLS CUI [1])

Neurological examination

Code List

Neurological examination

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])

Gynecological Examination

Item

Gynecological Examination

text

C0200044 (UMLS CUI [1])

Gynecological Examination

Code List

Gynecological Examination

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])

Urinary Tract and Kidney

Item

Urinary Tract and Kidney Examination

text

C0042027 (UMLS CUI [1,1])
C0227665 (UMLS CUI [1,2])

Urinary Tract and Kidney

Code List

Urinary Tract and Kidney Examination

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])

Other Findings

Item

Please specify any other clinically significant findings

text

C0159135 (UMLS CUI [1])

Concomitant agent

Item

Has concomitant medication been subject to change? If "Yes", please fill in concomitant medication form.

boolean

C2347852 (UMLS CUI [1])

CTCAE

Item

Recording of CTCAE: Have any AE occurred since the last Visit? If `Yes` please fill in AE-Form

boolean

C1516728 (UMLS CUI [1])

Laboratory results

Item Group

Laboratory results

Date of venous blood sampling

Item

Date of venous blood sampling

date

C0190979 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Time of laboratory procedure

Item

Time of laboratory procedure (according to laboratory sheet)

time

C0022885 (UMLS CUI [1])

Serologic tests Creatinine

Item

Creatinine measurement value

integer

C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])

Serologic tests Creatinine

Item

Is Creatinine value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])

Serologic tests Creatinine

Item

Are Creatinine measurement findings clinically significant? If `Yes`, please fill in AE- form.

boolean

C0036743 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])

Serologic tests Urea measurement

Item

Urea measurement value

integer

C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])

Serologic tests Urea measurement

Item

Is Urea measurement value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])

Serologic tests Urea measurement

Item

Are Urea measurement findings clinically significant? If `Yes`, please fill in AE-Form.

boolean

C0036743 (UMLS CUI [1,1])
C0523961 (UMLS CUI [1,2])

Serologic tests Bilirubin measurement

Item

Bilirubin measurement value

integer

C0036743 (UMLS CUI [1,1])
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])

Serologic tests Bilirubin measurement

Item

Are Bilirubin measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
C0344395 (UMLS CUI [1,2])

Serologic tests GPT measurement

Item

GPT measurement value

integer

C0036743 (UMLS CUI [1,1])
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])

Serologic measurement GPT measurement

Item

Are GPT measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
C0201836 (UMLS CUI [1,2])

Serologic tests GOT measurement

Item

GOT measurement value

integer

C0036743 (UMLS CUI [1,1])
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])

Serologic tests GOT measurement

Item

Are GOT measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])

Serologic tests GGT measurement

Item

GGT measurement value

integer

C0036743 (UMLS CUI [1,1])
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])

Serologic tests GGT measurement

Item

Are GGT measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
C0202035 (UMLS CUI [1,2])

Serologic tests Albumin measurement

Item

Albumin measurement value

integer

C0036743 (UMLS CUI [1,1])
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])

Serologic tests Albumin measurement

Item

Are Albumin measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
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])

Serologic tests serum potassium

Item

Is serum potassium measurement value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C0302353 (UMLS CUI [1,2])

Serologic tests serum potassium

Item

Are serum potassium measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
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])

Serologic tests serum sodium

Item

Is serum sodium measurement value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C0523891 (UMLS CUI [1,2])

Serologic tests serum sodium

Item

Are serum sodium measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
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])

Serologic tests serum calcium

Item

Is serum calcium measurement value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C0728876 (UMLS CUI [1,2])

Serologic measurement serum calcium

Item

Are serum calcium measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
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])

Serologic tests serum chloride

Item

Is serum chloride measurement value within normal range?

boolean

C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])

Serologic tests serum chloride

Item

Are serum chloride measurement findings clinically significant? If `Yes` , please fill in AE form.

boolean

C0036743 (UMLS CUI [1,1])
C1317978 (UMLS CUI [1,2])

Blood cell count: hemoglobin measurement

Item

Hemoglobin measurement value

integer

C0005771 (UMLS CUI [1,1])
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])

Blood cell count: hemoglobin measurement

Item

Are hemoglobin measurement findings clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
C0518015 (UMLS CUI [1,2])

Blood cell count hematocrit level

Item

Hematocrit level

integer

C0005771 (UMLS CUI [1,1])
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])

Blood cell count: Hematocrit level

Item

Are findings in hematocrit level clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

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])

Blood cell count: erythrocyte measurement

Item

Are findings in erythrocyte measurement clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

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])

Blood cell count:Leukocyte measurement

Item

Are findings in Leukocyte measurement clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

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])

Blood cell count:neutrophils count

Item

Are findings in neutrophils count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

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])

Blood cell count:lymphocyte count

Item

Are findings in lymphocyte count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

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])

Blood cell count: Monocyte count

Item

Are findings in monocyte count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

Blood cell count: Eosinophils count

Item

Is the count of eosinophils within normal range?

boolean

C0005771 (UMLS CUI [1,1])
C0200638 (UMLS CUI [1,2])

Blood cell count: eosinophils count

Item

Are findings in eosinophils count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

Blood cell count: Basophil count

Item

Is the count of basophils within normal range?

boolean

Blood cell count: Basophil count

Item

Are findings in basophil count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
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])

Blood cell count: platelets count

Item

Is the platelets count within normal range?

boolean

C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])

Blood cell count: platelets count

Item

Are findings in platelets count clinically significant? If `Yes`, please fill in AE form.

boolean

C0005771 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])

Tumor marker measurement

Item

Tumor marker CA125 measurement value

integer

C0474700 (UMLS CUI [1,1])
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])

Tumor marker measurement

Item

Are findings in tumor marker CA 125 clinically significant?

boolean

C0474700 (UMLS CUI [1,1])
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])

Urine Sample

Item

Urine Sample test results

text

C0200354 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])

Urine Sample

Code List

Urine Sample test results

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])

Inquiry of dose limiting toxicity

Item Group

Inquiry of dose limiting toxicity

Dose limiting toxicity

Item

Has a dose limiting toxicity been reached?

boolean

C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])

Date of dose limiting toxicity

Item

If dose limiting toxicity has been reached, please specify the date it occurred

date

C0011008 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])

Dose limiting toxicity

Item

Please specify the toxicities that have occurred and give the corresponding AE number

text

C1512043 (UMLS CUI [1,1])
C0013221 (UMLS CUI [1,2])

Maximum tolerated dose

Item

Has maximum tolerated dose been reached?

boolean

C0752079 (UMLS CUI [1])

Confirmation of correctness

Item Group

Confirmation of correctness

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])

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Visit 8 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv

Case Report Form (HIPEC) Visit 8

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