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ID

37770

Beskrivning

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

Nyckelord

Versioner (2)
  1. 2019-08-22 2019-08-22 -
  2. 2019-08-23 2019-08-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 augusti 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

    Engelsk

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

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Center Number
    Beskrivning

    Center Number

    Datatyp

    text

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

    Patient Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1709561
    Patient ID
    Beskrivning

    Patient ID

    Datatyp

    text

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

    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?
    Beskrivning

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

    Datatyp

    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
    Significant Medical/ Surgical History and Physical Examination
    Beskrivning

    Significant Medical/ Surgical History and Physical Examination

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

    Diagnosis

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0011900
    Date of Diagnosis
    Beskrivning

    Date of Diagnosis

    Datatyp

    partialDate

    Alias
    UMLS CUI [1]
    C2316983
    Status of Disease
    Beskrivning

    Status of Disease

    Datatyp

    integer

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

    History of Ovarian Cancer

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

    Date of Original Diagnosis

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2316983
    Date of Relapse
    Beskrivning

    Date of Relapse

    Datatyp

    date

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

    (please choose one)

    Datatyp

    integer

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

    Please record the current TNM stage of the patient

    Datatyp

    text

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

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

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0450454
    Metastatic
    Beskrivning

    Metastatic

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

    Metastasis - Date of Diagnosis

    Datatyp

    date

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

    Metastasis - Site

    Datatyp

    integer

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

    If other site of metastasis, specify.

    Datatyp

    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)
    Beskrivning

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

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

    Sample Date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    Laboratory Name
    Beskrivning

    Laboratory Name

    Datatyp

    text

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

    CA-125 Value

    Datatyp

    integer

    Måttenheter
    • U/mL
    Alias
    UMLS CUI [1]
    C0201549
    U/mL
    Tillbaka till toppen

    Similar models

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

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    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)
    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
    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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