ID

37766

Beschreibung

Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Stichworte

Versionen (2)
  1. 22.08.19 22.08.19 -
  2. 23.08.19 23.08.19 -
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GlaxoSmithKline

Hochgeladen am

22. August 2019

DOI

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Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308

Englisch

Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

1 Formulare  
Significant Medical/ Surgical History and Physical Examination
Beschreibung

Significant Medical/ Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
Beschreibung

If ”Yes“, please provide diagnosis below listing no more than one diagnosis per line.

Datentyp

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2]
C0012634
UMLS CUI [3,1]
C2603343
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0439849
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Center Number
Beschreibung

Center Number

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschreibung

Patient Number

Datentyp

text

Alias
UMLS CUI [1]
C1709561
Patient ID
Beschreibung

Patient ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Significant Medical/ Surgical History and Physical Examination
Beschreibung

Significant Medical/ Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Diagnosis
Beschreibung

Diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Date of Diagnosis
Beschreibung

Date of Diagnosis

Datentyp

partialDate

Alias
UMLS CUI [1]
C2316983
Status of Disease
Beschreibung

Status of Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0699749
History of Ovarian Cancer
Beschreibung

History of Ovarian Cancer

Alias
UMLS CUI-1
C0029925
UMLS CUI-2
C0262926
Date of Original Diagnosis
Beschreibung

Date of Original Diagnosis

Datentyp

date

Alias
UMLS CUI [1]
C2316983
Date of Relapse
Beschreibung

Date of Relapse

Datentyp

date

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
Primary Tumor Diagnosis
Beschreibung

(please choose one)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0011900
Please record the current TNM stage of the patient
Beschreibung

Please record the current TNM stage of the patient

Datentyp

text

Alias
UMLS CUI [1]
C1302362
FIGO Stage of current disease
Beschreibung

(please choose one) NOTE: Patient is ONL Y eligible if she is stage IIIB, IIIC or IV.

Datentyp

integer

Alias
UMLS CUI [1]
C0450454
Metastatic
Beschreibung

Metastatic

Alias
UMLS CUI-1
C0027627
Metastasis - Date of Diagnosis
Beschreibung

Metastasis - Date of Diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C2316983
UMLS CUI [1,2]
C0027627
Metastasis - Site
Beschreibung

Metastasis - Site

Datentyp

integer

Alias
UMLS CUI [1]
C0807944
If other site of metastasis, specify.
Beschreibung

If other site of metastasis, specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0807944
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Tumor Marker (CA-125) (7 days prior to Day 1)
Beschreibung

Tumor Marker (CA-125) (7 days prior to Day 1)

Alias
UMLS CUI-1
C0474700
UMLS CUI-2
C0201549
Sample Date
Beschreibung

Sample Date

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Laboratory Name
Beschreibung

Laboratory Name

Datentyp

text

Alias
UMLS CUI [1]
C3258037
CA-125 Value
Beschreibung

CA-125 Value

Datentyp

integer

Maßeinheiten
  • U/mL
Alias
UMLS CUI [1]
C0201549
U/mL
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Ähnliche Modelle

Screening - Significant Medical/ Surgical History and Physical Examination; History of Ovarian Cancer; Tumor Marker

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Significant Medical/ Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
Item
Is the patient suffering from or has she ever suffered from any significant medical or surgical condition not related to the study indication?
boolean
C0543467 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C2603343 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
Item Group
Administrative
C1320722 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1709561 (UMLS CUI [1])
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Item Group
Significant Medical/ Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Date of Diagnosis
Item
Date of Diagnosis
partialDate
C2316983 (UMLS CUI [1])
Item
Status of Disease
integer
C0699749 (UMLS CUI [1])
Status of Disease
Code List
Status of Disease
CL Item
Past (1)
CL Item
Current/ Active (2)
Item Group
History of Ovarian Cancer
C0029925 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of Original Diagnosis
Item
Date of Original Diagnosis
date
C2316983 (UMLS CUI [1])
Date of Relapse
Item
Date of Relapse
date
C0035020 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Primary Tumor Diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Primary Tumor Diagnosis
Code List
Primary Tumor Diagnosis
CL Item
Epithelial ovarian carcinoma  (1)
CL Item
Primary peritoneal carcinoma  (2)
CL Item
Fallopian tube carcinoma  (3)
CL Item
Tumors of mixed mullerian origin (4)
Please record the current TNM stage of the patient
Item
Please record the current TNM stage of the patient
text
C1302362 (UMLS CUI [1])
Item
FIGO Stage of current disease
integer
C0450454 (UMLS CUI [1])
FIGO Stage of current disease
Code List
FIGO Stage of current disease
CL Item
IIIB Macroscopic peritoneal metastasis beyond pelvis 2 cm or less in greatest dimension.  (1)
CL Item
IIIC Peritoneal metastasis beyond pelvis more than 2 cm in greatest dimension and/or regional lymph node metastasis.  (2)
CL Item
IV Distant metastasis (excludes peritoneal metastasis). (3)
Item Group
Metastatic
C0027627 (UMLS CUI-1)
Metastasis - Date of Diagnosis
Item
Metastasis - Date of Diagnosis
date
C2316983 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Item
Metastasis - Site
integer
C0807944 (UMLS CUI [1])
Metastasis - Site
Code List
Metastasis - Site
CL Item
Lymph Node  (1)
CL Item
Liver  (2)
CL Item
Other, Specify. (3)
If other site of metastasis, specify.
Item
If other site of metastasis, specify.
text
C0807944 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Tumor Marker (CA-125) (7 days prior to Day 1)
C0474700 (UMLS CUI-1)
C0201549 (UMLS CUI-2)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
CA-125 Value
Item
CA-125 Value
integer
C0201549 (UMLS CUI [1])
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