ID

35361

Beschrijving

Immunological Markers Screening for Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02222753

Link

https://clinicaltrials.gov/show/NCT02222753

Trefwoorden

Versies (1)
  1. 02-03-19 02-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 maart 2019

DOI

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Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT02222753

Engels

Eligibility Colorectal Cancer NCT02222753

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have a histologically proven adenocarcinoma of colon or rectum cancer.
Beschrijving

Adenocarcinoma of colon | Adenocarcinoma of rectum

Datatype

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
patients must have a performance status of 0,1, or 2 by the southwest oncology group criteria.
Beschrijving

SWOG performance status

Datatype

boolean

Alias
UMLS CUI [1,1]
C1519429
UMLS CUI [1,2]
C1518965
patients must have recovered from any effects of surgery.
Beschrijving

Effect of surgery Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0544721
UMLS CUI [1,2]
C1115804
evaluable disease must be present outside radiation field. at least 3 weeks must have elapsed after discontinuation of radiation therapy.
Beschrijving

Evaluable Disease outside Radiation Field | Therapeutic radiology procedure Discontinued

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516986
UMLS CUI [1,2]
C0205101
UMLS CUI [1,3]
C1882536
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1444662
patients must provide a signed consent to participate in the study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients must complete all questionnaires.
Beschrijving

Questionnaires Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
Beschrijving

Peptic Ulcer | Gastroesophageal reflux

Datatype

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2]
C0017168
history of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
Beschrijving

Cancer Other | Exception Curative treatment Malignant Neoplasms | Exception Disease Free

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0332296
unresolved bacterial infection requiring treatment with antibiotics.
Beschrijving

Bacterial Infection Resolution Lacking | Patient need for Antibiotics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0003232
pregnant or lactating women may not participate in the study.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients known to have hiv-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with hiv-1 and the potential for serious interaction with anti-hiv medications.
Beschrijving

HIV-1 infection

Datatype

boolean

Alias
UMLS CUI [1]
C2363741
gilbert's disease.
Beschrijving

Gilbert Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0017551
other serious concurrent infection
Beschrijving

Communicable Disease Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Beschrijving

Heart Disease Poorly controlled | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0003811
UMLS CUI [5]
C0027051
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Similar models

Eligibility Colorectal Cancer NCT02222753

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
patient must have a histologically proven adenocarcinoma of colon or rectum cancer.
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
SWOG performance status
Item
patients must have a performance status of 0,1, or 2 by the southwest oncology group criteria.
boolean
C1519429 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Effect of surgery Patient recovered
Item
patients must have recovered from any effects of surgery.
boolean
C0544721 (UMLS CUI [1,1])
C1115804 (UMLS CUI [1,2])
Evaluable Disease outside Radiation Field | Therapeutic radiology procedure Discontinued
Item
evaluable disease must be present outside radiation field. at least 3 weeks must have elapsed after discontinuation of radiation therapy.
boolean
C1516986 (UMLS CUI [1,1])
C0205101 (UMLS CUI [1,2])
C1882536 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Informed Consent
Item
patients must provide a signed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Questionnaires Completion
Item
patients must complete all questionnaires.
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Peptic Ulcer | Gastroesophageal reflux
Item
patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
boolean
C0030920 (UMLS CUI [1])
C0017168 (UMLS CUI [2])
Cancer Other | Exception Curative treatment Malignant Neoplasms | Exception Disease Free
Item
history of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0332296 (UMLS CUI [3,3])
Bacterial Infection Resolution Lacking | Patient need for Antibiotics
Item
unresolved bacterial infection requiring treatment with antibiotics.
boolean
C0004623 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women may not participate in the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV-1 infection
Item
patients known to have hiv-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with hiv-1 and the potential for serious interaction with anti-hiv medications.
boolean
C2363741 (UMLS CUI [1])
Gilbert Disease
Item
gilbert's disease.
boolean
C0017551 (UMLS CUI [1])
Communicable Disease Serious
Item
other serious concurrent infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Heart Disease Poorly controlled | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia | Myocardial Infarction
Item
clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
boolean
C0018799 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C1956346 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
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