ID

32584

Beskrivning

Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection; ODM derived from: https://clinicaltrials.gov/show/NCT00362713

Länk

https://clinicaltrials.gov/show/NCT00362713

Nyckelord

Versioner (1)
  1. 2018-11-07 2018-11-07 -
Rättsinnehavare

See clinicaltrials.gov

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7 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Transitional Cell Carcinoma NCT00362713

Engelsk

Eligibility Transitional Cell Carcinoma NCT00362713

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
previously untreated urothelial cancer requiring surgery for treatment
Beskrivning

Urothelial carcinoma untreated | Operative Surgical Procedure Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007138
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1514873
ineligible for chemotherapy
Beskrivning

Ineligibility Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0392920
adequate hematologic, kidney and liver function
Beskrivning

Hematologic function | Renal function | Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
Beskrivning

Females & males of reproductive potential Sexually active Contraceptive methods Unwilling | Females & males of reproductive potential Sexually active Contraceptive methods Unable | Partner Contraceptive methods Unwilling | Partner Contraceptive methods Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [1,4]
C0558080
UMLS CUI [2,1]
C4034483
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1299582
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0682323
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1299582
women who are pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women with a positive pregnancy test on enrollment prior to study drug administration
Beskrivning

Pregnancy test positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0240802
prior treatment with ipilimumab or other anti-ctla4 antibody, or a cd137 agonist
Beskrivning

Ipilimumab | Anti-CTLA-4 Monoclonal Antibody | CD137 Agonist

Datatyp

boolean

Alias
UMLS CUI [1]
C1367202
UMLS CUI [2]
C4289973
UMLS CUI [3,1]
C0214721
UMLS CUI [3,2]
C2987634
concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
autoimmune disease: subjects with a documented history of inflammatory bowel disease (including crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., wegener's granulomatosis]). subjects with motor neuropathy considered of autoimmune origin (e.g., guillain-barre syndrome) are excluded from this study
Beskrivning

Autoimmune Disease | Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis | Disease Symptomatic | Rheumatoid Arthritis | Systemic Scleroderma | Lupus Erythematosus, Systemic | Autoimmune vasculitis | Granulomatosis with polyangiitis | Guillain-Barre Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0010346
UMLS CUI [4]
C0009324
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0231220
UMLS CUI [6]
C0003873
UMLS CUI [7]
C0036421
UMLS CUI [8]
C0024141
UMLS CUI [9]
C1328843
UMLS CUI [10]
C3495801
UMLS CUI [11]
C0018378
patients deemed ineligible for surgery
Beskrivning

Ineligibility Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0543467
any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
Beskrivning

Vaccine Therapy Prevention Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042209
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C0009450
concomitant therapy with any of the following: il-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
Beskrivning

IL-2 | Interferon | Immunotherapy | Chemotherapy | Immunosuppressive Agents | Therapies, Investigational | CORTICOSTEROIDS FOR SYSTEMIC USE chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0021756
UMLS CUI [2]
C3652465
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0392920
UMLS CUI [5]
C0021081
UMLS CUI [6]
C0949266
UMLS CUI [7,1]
C3653708
UMLS CUI [7,2]
C0205191
prior radiation therapy for urothelial cancer
Beskrivning

Prior radiation therapy Urothelial carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0007138
positive screening tests for or any prior history of hiv, hepatitis b or hepatitis c
Beskrivning

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
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Similar models

Eligibility Transitional Cell Carcinoma NCT00362713

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Urothelial carcinoma untreated | Operative Surgical Procedure Required
Item
previously untreated urothelial cancer requiring surgery for treatment
boolean
C0007138 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Ineligibility Chemotherapy
Item
ineligible for chemotherapy
boolean
C1512714 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, kidney and liver function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Females & males of reproductive potential Sexually active Contraceptive methods Unwilling | Females & males of reproductive potential Sexually active Contraceptive methods Unable | Partner Contraceptive methods Unwilling | Partner Contraceptive methods Unable
Item
sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
boolean
C4034483 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C4034483 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0682323 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pregnancy test positive
Item
women with a positive pregnancy test on enrollment prior to study drug administration
boolean
C0240802 (UMLS CUI [1])
Ipilimumab | Anti-CTLA-4 Monoclonal Antibody | CD137 Agonist
Item
prior treatment with ipilimumab or other anti-ctla4 antibody, or a cd137 agonist
boolean
C1367202 (UMLS CUI [1])
C4289973 (UMLS CUI [2])
C0214721 (UMLS CUI [3,1])
C2987634 (UMLS CUI [3,2])
Cancer Other | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix | Exception Disease Free of
Item
concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1880198 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1880198 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
Autoimmune Disease | Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis | Disease Symptomatic | Rheumatoid Arthritis | Systemic Scleroderma | Lupus Erythematosus, Systemic | Autoimmune vasculitis | Granulomatosis with polyangiitis | Guillain-Barre Syndrome
Item
autoimmune disease: subjects with a documented history of inflammatory bowel disease (including crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., wegener's granulomatosis]). subjects with motor neuropathy considered of autoimmune origin (e.g., guillain-barre syndrome) are excluded from this study
boolean
C0004364 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
C0009324 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0003873 (UMLS CUI [6])
C0036421 (UMLS CUI [7])
C0024141 (UMLS CUI [8])
C1328843 (UMLS CUI [9])
C3495801 (UMLS CUI [10])
C0018378 (UMLS CUI [11])
Ineligibility Operative Surgical Procedures
Item
patients deemed ineligible for surgery
boolean
C1512714 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Vaccine Therapy Prevention Communicable Disease
Item
any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
boolean
C0042209 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
IL-2 | Interferon | Immunotherapy | Chemotherapy | Immunosuppressive Agents | Therapies, Investigational | CORTICOSTEROIDS FOR SYSTEMIC USE chronic
Item
concomitant therapy with any of the following: il-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
boolean
C0021756 (UMLS CUI [1])
C3652465 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
C0949266 (UMLS CUI [6])
C3653708 (UMLS CUI [7,1])
C0205191 (UMLS CUI [7,2])
Prior radiation therapy Urothelial carcinoma
Item
prior radiation therapy for urothelial cancer
boolean
C0279134 (UMLS CUI [1,1])
C0007138 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
Item
positive screening tests for or any prior history of hiv, hepatitis b or hepatitis c
boolean
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
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