ID

44350

Description

Scope Pilot Research Study; ODM derived from: https://clinicaltrials.gov/show/NCT00893503

Link

https://clinicaltrials.gov/show/NCT00893503

Keywords

Versions (2)
  1. 1/2/18 1/2/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00893503

English

Eligibility Colorectal Cancer NCT00893503

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients on gastrointestinal wait-lists for screening colonoscopy
Description

Waiting Lists (patient) gastrointestinal Screening colonoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0043010
UMLS CUI [1,2]
C0521362
UMLS CUI [1,3]
C1882982
patients that are 50 - 75 years of age at average risk for colorectal cancer or patients that are 40 - 75 years of age and at high risk for colorectal cancer
Description

Age | Average Risk Colorectal Carcinoma | High risk of Colorectal Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1510992
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0009402
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0009402
patients that are healthy or have co-morbidities that are currently stable
Description

Healthy Volunteers | Comorbidity Stable

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205360
patients that are willing to complete 1 fobt, 2 fits, urine for metabolomics, attend an education session, colonoscopy and evaluate the scope program and education resources.
Description

FOBT Quantity | FIT Quantity | Urine Metabolome | Education Session | Colonoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0201811
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2700166
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0042036
UMLS CUI [3,2]
C2350399
UMLS CUI [4,1]
C0013622
UMLS CUI [4,2]
C1883016
UMLS CUI [5]
C0009378
individuals will be eligible to participate in the pilot if their last colonoscopy was a minimum of five (5) years ago. less than 5 years is acceptable if the procedure report on the last colonoscopy recommends repeat colonoscopy at an earlier interval.
Description

Colonoscopy | Colonoscopy Repeat Recommended

Data type

boolean

Alias
UMLS CUI [1]
C0009378
UMLS CUI [2,1]
C0009378
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C0034866
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
under 40 years of age or over 75 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
inability to understand / sign informed consent (applies to individuals that do not speak or read english)
Description

Informed Consent Unable | Lacking Able to speak English Language | Lacking Able to read English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564215
UMLS CUI [2,3]
C0376245
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C0586740
UMLS CUI [3,3]
C0376245
use of warfarin or any anticoagulant medications (includes low molecular weight heparin)
Description

Warfarin | Anticoagulants | Heparin, Low-Molecular-Weight

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0019139
rectal bleeding
Description

Rectal hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0267596
past history of failed or extremely difficult colonoscopy
Description

Colonoscopy failed | Colonoscopy Extremely Difficult

Data type

boolean

Alias
UMLS CUI [1,1]
C0009378
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0009378
UMLS CUI [2,2]
C3843354
insulin dependent diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of inflammatory bowel disease
Description

Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
use of bi-pap or home oxygen
Description

BIPAP | Home oxygen therapy

Data type

boolean

Alias
UMLS CUI [1]
C1956423
UMLS CUI [2]
C1960973
asthma or copd described as severe
Description

Severe asthma | COPD Severe

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0205082
chronic disease that is suspected / under investigation but nyd
Description

Chronic disease Suspected

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0750491
chronic / acute disease process that is not stable or not in remission
Description

Chronic disease Unstable | Disease Unstable | Chronic disease Remission Lacking | Disease Remission Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0544452
UMLS CUI [3,3]
C0332268
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0544452
UMLS CUI [4,3]
C0332268
possible lynch syndrome
Description

Lynch syndrome Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C1333990
UMLS CUI [1,2]
C0332149
renal disease requiring any type of dialysis
Description

Kidney Disease Requirement Dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0011946
bmi > 35
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
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Similar models

Eligibility Colorectal Cancer NCT00893503

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Waiting Lists (patient) gastrointestinal Screening colonoscopy
Item
patients on gastrointestinal wait-lists for screening colonoscopy
boolean
C0043010 (UMLS CUI [1,1])
C0521362 (UMLS CUI [1,2])
C1882982 (UMLS CUI [1,3])
Age | Average Risk Colorectal Carcinoma | High risk of Colorectal Carcinoma
Item
patients that are 50 - 75 years of age at average risk for colorectal cancer or patients that are 40 - 75 years of age and at high risk for colorectal cancer
boolean
C0001779 (UMLS CUI [1])
C1510992 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0009402 (UMLS CUI [2,3])
C0332167 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
Healthy Volunteers | Comorbidity Stable
Item
patients that are healthy or have co-morbidities that are currently stable
boolean
C1708335 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
FOBT Quantity | FIT Quantity | Urine Metabolome | Education Session | Colonoscopy
Item
patients that are willing to complete 1 fobt, 2 fits, urine for metabolomics, attend an education session, colonoscopy and evaluate the scope program and education resources.
boolean
C0201811 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2700166 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0042036 (UMLS CUI [3,1])
C2350399 (UMLS CUI [3,2])
C0013622 (UMLS CUI [4,1])
C1883016 (UMLS CUI [4,2])
C0009378 (UMLS CUI [5])
Colonoscopy | Colonoscopy Repeat Recommended
Item
individuals will be eligible to participate in the pilot if their last colonoscopy was a minimum of five (5) years ago. less than 5 years is acceptable if the procedure report on the last colonoscopy recommends repeat colonoscopy at an earlier interval.
boolean
C0009378 (UMLS CUI [1])
C0009378 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0034866 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
under 40 years of age or over 75 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unable | Lacking Able to speak English Language | Lacking Able to read English Language
Item
inability to understand / sign informed consent (applies to individuals that do not speak or read english)
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C0564215 (UMLS CUI [2,2])
C0376245 (UMLS CUI [2,3])
C0332268 (UMLS CUI [3,1])
C0586740 (UMLS CUI [3,2])
C0376245 (UMLS CUI [3,3])
Warfarin | Anticoagulants | Heparin, Low-Molecular-Weight
Item
use of warfarin or any anticoagulant medications (includes low molecular weight heparin)
boolean
C0043031 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0019139 (UMLS CUI [3])
Rectal hemorrhage
Item
rectal bleeding
boolean
C0267596 (UMLS CUI [1])
Colonoscopy failed | Colonoscopy Extremely Difficult
Item
past history of failed or extremely difficult colonoscopy
boolean
C0009378 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0009378 (UMLS CUI [2,1])
C3843354 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
insulin dependent diabetes
boolean
C0011854 (UMLS CUI [1])
Inflammatory Bowel Disease
Item
history of inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
BIPAP | Home oxygen therapy
Item
use of bi-pap or home oxygen
boolean
C1956423 (UMLS CUI [1])
C1960973 (UMLS CUI [2])
Severe asthma | COPD Severe
Item
asthma or copd described as severe
boolean
C0581126 (UMLS CUI [1])
C0024117 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Chronic disease Suspected
Item
chronic disease that is suspected / under investigation but nyd
boolean
C0008679 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
Chronic disease Unstable | Disease Unstable | Chronic disease Remission Lacking | Disease Remission Lacking
Item
chronic / acute disease process that is not stable or not in remission
boolean
C0008679 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C0544452 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0544452 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
Lynch syndrome Possible
Item
possible lynch syndrome
boolean
C1333990 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
Kidney Disease Requirement Dialysis
Item
renal disease requiring any type of dialysis
boolean
C0022658 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])
Body mass index
Item
bmi > 35
boolean
C1305855 (UMLS CUI [1])
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