ID

30675

Beschrijving

A Study of Vismodegib (GDC-0449, Hedgehog Pathway Inhibitor) With Concurrent Chemotherapy and Bevacizumab As First-Line Therapy for Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00636610

Link

https://clinicaltrials.gov/show/NCT00636610

Trefwoorden

Versies (1)
  1. 19-06-18 19-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juni 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Metastatic Colorectal Cancer NCT00636610

Engels

Eligibility Metastatic Colorectal Cancer NCT00636610

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically confirmed metastatic colorectal cancer (crc)
Beschrijving

Colorectal cancer metastatic

Datatype

boolean

Alias
UMLS CUI [1]
C0948380
representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study
Beschrijving

Availability of Tumor tissue sample Paraffin Block | Availability of Unstained Specimen Quantity | Pathology report

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C1519524
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1883469
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0807321
eastern cooperative oncology group (ecog) performance status 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
adequate hematopoetic capacity
Beschrijving

Capacity Hematopoietic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516240
UMLS CUI [1,2]
C0229601
adequate hepatic function
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
adequate renal function
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
use of an effective method of barrier contraception (for women of childbearing potential)
Beschrijving

Childbearing Potential Barrier Contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
signed informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy for metastatic crc or adjuvant chemotherapy for crc within the prior 6 months
Beschrijving

Prior Chemotherapy Colorectal cancer metastatic | Adjuvant Chemotherapy Colorectal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0948380
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0009402
clinically suspected or confirmed cns metastases or carcinomatous meningitis
Beschrijving

CNS metastases Suspected | CNS metastases | Meningeal Carcinomatosis Suspected | Meningeal Carcinomatosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0686377
UMLS CUI [3,1]
C0220654
UMLS CUI [3,2]
C0750491
UMLS CUI [4]
C0220654
major surgical procedure within 4 weeks prior to the first day of treatment in this study (day 1)
Beschrijving

Major surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
pelvic radiation within 2 weeks prior to day 1
Beschrijving

Irradiation of pelvis

Datatype

boolean

Alias
UMLS CUI [1]
C0747411
wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction
Beschrijving

Wound dehiscence Requirement Intervention | Gastrointestinal perforation | Intestinal Obstruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0259768
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0184661
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0021843
pregnancy or lactation
Beschrijving

Pregnancy | Lactation

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
uncontrolled medical illnesses including the following: infection requiring intravenous (iv) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication
Beschrijving

Illness Uncontrolled | Communicable Disease Requirement Antibiotics Intravenous | Congestive heart failure Uncontrolled | Uncontrolled hypertension

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [2,4]
C1522726
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C1868885
thromboembolic disease
Beschrijving

Thromboembolism

Datatype

boolean

Alias
UMLS CUI [1]
C0040038
history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
Beschrijving

Comorbidity | Dysfunction Metabolic | Physical Examination Finding | Laboratory test finding | Medical contraindication Investigational New Drugs | Condition Affecting Interpretation Research results | Condition High risk of Complications of treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0243095
UMLS CUI [4]
C0587081
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0013230
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C0332167
UMLS CUI [7,3]
C0679861
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Similar models

Eligibility Metastatic Colorectal Cancer NCT00636610

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Colorectal cancer metastatic
Item
histologically confirmed metastatic colorectal cancer (crc)
boolean
C0948380 (UMLS CUI [1])
Availability of Tumor tissue sample Paraffin Block | Availability of Unstained Specimen Quantity | Pathology report
Item
representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, must be confirmed to be available and requested at any time prior to entry of study
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1519524 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0807321 (UMLS CUI [3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Capacity Hematopoietic
Item
adequate hematopoetic capacity
boolean
C1516240 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
Liver function
Item
adequate hepatic function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Childbearing Potential Barrier Contraception
Item
use of an effective method of barrier contraception (for women of childbearing potential)
boolean
C3831118 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Colorectal cancer metastatic | Adjuvant Chemotherapy Colorectal Carcinoma
Item
prior chemotherapy for metastatic crc or adjuvant chemotherapy for crc within the prior 6 months
boolean
C1514457 (UMLS CUI [1,1])
C0948380 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
CNS metastases Suspected | CNS metastases | Meningeal Carcinomatosis Suspected | Meningeal Carcinomatosis
Item
clinically suspected or confirmed cns metastases or carcinomatous meningitis
boolean
C0686377 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C0220654 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0220654 (UMLS CUI [4])
Major surgery
Item
major surgical procedure within 4 weeks prior to the first day of treatment in this study (day 1)
boolean
C0679637 (UMLS CUI [1])
Irradiation of pelvis
Item
pelvic radiation within 2 weeks prior to day 1
boolean
C0747411 (UMLS CUI [1])
Wound dehiscence Requirement Intervention | Gastrointestinal perforation | Intestinal Obstruction
Item
wound dehiscence requiring intervention, gastrointestinal perforation, or bowel obstruction
boolean
C0259768 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0151664 (UMLS CUI [2])
C0021843 (UMLS CUI [3])
Pregnancy | Lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
Illness Uncontrolled | Communicable Disease Requirement Antibiotics Intravenous | Congestive heart failure Uncontrolled | Uncontrolled hypertension
Item
uncontrolled medical illnesses including the following: infection requiring intravenous (iv) antibiotics, congestive heart failure not controlled with medication, hypertension not controlled with medication
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C1522726 (UMLS CUI [2,4])
C0018802 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C1868885 (UMLS CUI [4])
Thromboembolism
Item
thromboembolic disease
boolean
C0040038 (UMLS CUI [1])
Comorbidity | Dysfunction Metabolic | Physical Examination Finding | Laboratory test finding | Medical contraindication Investigational New Drugs | Condition Affecting Interpretation Research results | Condition High risk of Complications of treatment
Item
history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
boolean
C0009488 (UMLS CUI [1])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
C0587081 (UMLS CUI [4])
C1301624 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
C0348080 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0348080 (UMLS CUI [7,1])
C0332167 (UMLS CUI [7,2])
C0679861 (UMLS CUI [7,3])
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