ID

28286

Descripción

Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00895323

Link

https://clinicaltrials.gov/show/NCT00895323

Palabras clave

Versiones (1)
  1. 2/1/18 2/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00895323

Inglés

Eligibility Colorectal Cancer NCT00895323

1 formularios  
Criteria
Descripción

Criteria

histologically confirmed colorectal cancer
Descripción

Colorectal Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009402
radiological documentation of disease is preferred, but not required
Descripción

Disease Documentation Radiologic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205483
patient characteristics:
Descripción

Client Characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0815172
karnofsky performance status 70-100%
Descripción

Karnofsky Performance Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy ≥ 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
wbc ≥ 3,000/mm³
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
neutrophil count ≥ 1,500/mm³
Descripción

Neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0200633
platelet count ≥ 100,000/mm³
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine normal
Descripción

Serum creatinine normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438244
bilirubin ≤ 1.5 times upper limit of normal (uln)
Descripción

Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
ast/alt < 2 times uln
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
not pregnant or nursing
Descripción

Exclusion Criteria | Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
fertile patients must use effective contraception during and for 1 month after completion of study therapy
Descripción

Fertility Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
no medical conditions that might prevent full participation in protocol-required testing or follow-up
Descripción

Exclusion | Medical condition Preventing Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0525058
no institutionalized patients (e.g., in prisons or mental health institutions)
Descripción

Exclusion Criteria | Institutionalized Persons | Prisoners

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0376326
UMLS CUI [3]
C0033167
prior concurrent therapy:
Descripción

Therapeutic procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0087111
no concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
Descripción

Exclusion Criteria | Chemotherapy compromises Protocol Assessment | Therapeutic procedure compromises Protocol Assessment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C2348563
UMLS CUI [2,4]
C1516048
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C2348563
UMLS CUI [3,4]
C1516048
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Similar models

Eligibility Colorectal Cancer NCT00895323

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Colorectal Carcinoma
Item
histologically confirmed colorectal cancer
boolean
C0009402 (UMLS CUI [1])
Disease Documentation Radiologic
Item
radiological documentation of disease is preferred, but not required
boolean
C0012634 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205483 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status 70-100%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc ≥ 3,000/mm³
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophil count ≥ 1,500/mm³
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Serum creatinine normal
Item
serum creatinine normal
boolean
C0438244 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin ≤ 1.5 times upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt < 2 times uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Exclusion Criteria | Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0680251 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Fertility Contraceptive methods
Item
fertile patients must use effective contraception during and for 1 month after completion of study therapy
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion | Medical condition Preventing Protocol Compliance
Item
no medical conditions that might prevent full participation in protocol-required testing or follow-up
boolean
C2828389 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Exclusion Criteria | Institutionalized Persons | Prisoners
Item
no institutionalized patients (e.g., in prisons or mental health institutions)
boolean
C0680251 (UMLS CUI [1])
C0376326 (UMLS CUI [2])
C0033167 (UMLS CUI [3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Exclusion Criteria | Chemotherapy compromises Protocol Assessment | Therapeutic procedure compromises Protocol Assessment
Item
no concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
boolean
C0680251 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C1516048 (UMLS CUI [2,4])
C0087111 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C1516048 (UMLS CUI [3,4])
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