ID

44306

Description

A Study to Determine the Activity of SCH 717454 in Subjects With Relapsed or Recurrent Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00551213

Link

https://clinicaltrials.gov/show/NCT00551213

Keywords

Versions (2)
  1. 12/21/17 12/21/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Colorectal Cancer NCT00551213

English

Eligibility Colorectal Cancer NCT00551213

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
older than 18 years of age, of any race, and gender;
Description

Age | Racial group | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0034510
UMLS CUI [3]
C0079399
diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy;
Description

Colorectal cancer recurrent | First line treatment | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0854750
UMLS CUI [2]
C1708063
UMLS CUI [3]
C0242656
must have a ct or mri scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate;
Description

Tumor Growth rate CT scan | Tumor Growth rate MRI scan

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0449249
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0449249
UMLS CUI [2,3]
C0024485
must have measurable disease on a ct or mri study, performed during screening;
Description

Measurable Disease CT | Measurable Disease MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0040405
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0024485
must have an eastern cooperative oncology group (ecog) performance status of <=2 and a minimum life expectancy of ≥4 months;
Description

ECOG performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
must have adequate organ function within 3 weeks prior to treatment assignment
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of another malignancy;
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;
Description

Metastatic Malignant Neoplasm to the Leptomeninges Treated | Metastatic Malignant Neoplasm to the Leptomeninges untreated | CNS lesion metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1704231
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0742468
UMLS CUI [3,2]
C1522484
surgery within 3 weeks;
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
radiation therapy within 6 weeks;
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
a history of uncontrolled diabetes mellitus, defined as a hemoglobin a1c of >7.5% in a patient with known diabetes mellitus;
Description

Diabetic - poor control | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0202054
a recent myocardial infarction (within the past year); or a subject who at the time of screening presents with unstable or uncontrolled angina, new york heart association class iii or iv congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality;
Description

Myocardial Infarction | Angina, Unstable | Angina Pectoris Uncontrolled | Congestive heart failure New York Heart Association Classification | Uncontrolled hypertension | Cardiac Arrhythmia | ECG abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C1868885
UMLS CUI [6]
C0003811
UMLS CUI [7]
C0522055
an active infection;
Description

Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009450
a subject with clinically significant hepatitis at screening, or a subject that is hepatitis c antibody positive, hepatitis b surface antigen positive, or human immunodeficiency virus seropositive.
Description

Hepatitis | Hepatitis C antibody positive | Hepatitis B surface antigen positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0019699
Back to the top of the page

Similar models

Eligibility Colorectal Cancer NCT00551213

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Racial group | Gender
Item
older than 18 years of age, of any race, and gender;
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Colorectal cancer recurrent | First line treatment | Disease Progression
Item
diagnosis of histologically confirmed relapsed or recurrent colorectal carcinoma that has progressed on at least first-line therapy;
boolean
C0854750 (UMLS CUI [1])
C1708063 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Tumor Growth rate CT scan | Tumor Growth rate MRI scan
Item
must have a ct or mri scan performed at some point during their immediate prior treatment or observation in order to determine tumor growth rate;
boolean
C0027651 (UMLS CUI [1,1])
C0449249 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0449249 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Measurable Disease CT | Measurable Disease MRI
Item
must have measurable disease on a ct or mri study, performed during screening;
boolean
C1513041 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
ECOG performance status | Life Expectancy
Item
must have an eastern cooperative oncology group (ecog) performance status of <=2 and a minimum life expectancy of ≥4 months;
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Organ function
Item
must have adequate organ function within 3 weeks prior to treatment assignment
boolean
C0678852 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
history of another malignancy;
boolean
C1707251 (UMLS CUI [1])
Metastatic Malignant Neoplasm to the Leptomeninges Treated | Metastatic Malignant Neoplasm to the Leptomeninges untreated | CNS lesion metastatic
Item
known treated or untreated leptomeningeal metastasis, or a metastatic central nervous system lesion;
boolean
C1704231 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0742468 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
Operative Surgical Procedures
Item
surgery within 3 weeks;
boolean
C0543467 (UMLS CUI [1])
Therapeutic radiology procedure
Item
radiation therapy within 6 weeks;
boolean
C1522449 (UMLS CUI [1])
Diabetic - poor control | Glucohemoglobin measurement
Item
a history of uncontrolled diabetes mellitus, defined as a hemoglobin a1c of >7.5% in a patient with known diabetes mellitus;
boolean
C0421258 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Angina Pectoris Uncontrolled | Congestive heart failure New York Heart Association Classification | Uncontrolled hypertension | Cardiac Arrhythmia | ECG abnormality
Item
a recent myocardial infarction (within the past year); or a subject who at the time of screening presents with unstable or uncontrolled angina, new york heart association class iii or iv congestive heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant electrocardiogram abnormality;
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C1868885 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0522055 (UMLS CUI [7])
Communicable Disease
Item
an active infection;
boolean
C0009450 (UMLS CUI [1])
Hepatitis | Hepatitis C antibody positive | Hepatitis B surface antigen positive | HIV Seropositivity
Item
a subject with clinically significant hepatitis at screening, or a subject that is hepatitis c antibody positive, hepatitis b surface antigen positive, or human immunodeficiency virus seropositive.
boolean
C0019158 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0019699 (UMLS CUI [4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial