ID

18482

Description

Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00109655

Link

https://clinicaltrials.gov/show/NCT00109655

Keywords

Versions (1)
  1. 11/7/16 11/7/16 -
Uploaded on

November 7, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Carcinoma, Transitional Cell NCT00109655

English

Eligibility Carcinoma, Transitional Cell NCT00109655

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
high grade non-muscle invasive bladder cancer (stages ta, t1 and/or cis - carcinoma in situ). high grade being defined as g2 or g3 disease.
Description

Carcinoma of urinary bladder, invasive; Neoplasm Grading

Data type

boolean

Alias
UMLS CUI [1,1]
C1827293
UMLS CUI [1,2]
C3179006
failure of at least one prior treatment with bcg, defined as evidence of tcc on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last bcg treatment
Description

Bacillus Calmette-Guerin; cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0085957
UMLS CUI [1,2]
C0920425
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow, renal, liver and coagulation function
Description

Bone Marrow | Renal function | Liver function | Blood coagulation

Data type

boolean

Alias
UMLS CUI [1]
C0005953
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0005778
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hiv positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
use of anticoagulants such as coumadin or heparin
Description

Anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0003280
history of bleeding disorder
Description

Bleeding Risk

Data type

boolean

Alias
UMLS CUI [1]
C3251812
active systemic autoimmune disease or chronic immunodeficiency
Description

Autoimmune Diseases | Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
prior gene therapy
Description

gene therapy

Data type

boolean

Alias
UMLS CUI [1]
C0017296
uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Description

Cystitis | Bladder pain | Bladder spasm | Urinary Incontinence | Reduced bladder capacity

Data type

boolean

Alias
UMLS CUI [1]
C0010692
UMLS CUI [2]
C0232849
UMLS CUI [3]
C0426390
UMLS CUI [4]
C0042024
UMLS CUI [5]
C2721720
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Similar models

Eligibility Carcinoma, Transitional Cell NCT00109655

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinoma of urinary bladder, invasive; Neoplasm Grading
Item
high grade non-muscle invasive bladder cancer (stages ta, t1 and/or cis - carcinoma in situ). high grade being defined as g2 or g3 disease.
boolean
C1827293 (UMLS CUI [1,1])
C3179006 (UMLS CUI [1,2])
Bacillus Calmette-Guerin; cancer treatment
Item
failure of at least one prior treatment with bcg, defined as evidence of tcc on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last bcg treatment
boolean
C0085957 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow | Renal function | Liver function | Blood coagulation
Item
adequate bone marrow, renal, liver and coagulation function
boolean
C0005953 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005778 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive
boolean
C0019699 (UMLS CUI [1])
Anticoagulants
Item
use of anticoagulants such as coumadin or heparin
boolean
C0003280 (UMLS CUI [1])
Bleeding Risk
Item
history of bleeding disorder
boolean
C3251812 (UMLS CUI [1])
Autoimmune Diseases | Immunologic Deficiency Syndromes
Item
active systemic autoimmune disease or chronic immunodeficiency
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
gene therapy
Item
prior gene therapy
boolean
C0017296 (UMLS CUI [1])
Cystitis | Bladder pain | Bladder spasm | Urinary Incontinence | Reduced bladder capacity
Item
uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
boolean
C0010692 (UMLS CUI [1])
C0232849 (UMLS CUI [2])
C0426390 (UMLS CUI [3])
C0042024 (UMLS CUI [4])
C2721720 (UMLS CUI [5])
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