ID

35371

Descripción

A Study of Cologuard™ in an Average Risk Population Assessing a Three Year Test Interval; ODM derived from: https://clinicaltrials.gov/show/NCT02419716

Link

https://clinicaltrials.gov/show/NCT02419716

Palabras clave

Versiones (1)
  1. 3/3/19 3/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer Screening NCT02419716

Inglés

Eligibility Colorectal Cancer Screening NCT02419716

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject has been prescribed cologuard for colorectal cancer screening
Descripción

Cologuard Tests Colorectal cancer screening

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4528851
UMLS CUI [1,2]
C0281185
2. subject is at average risk for development of colorectal cancer
Descripción

Average Risk Colorectal Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0009402
3. subject is 50 years or older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
4. subject willing and able to sign informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subject had a colonoscopy in the previous 9 years
Descripción

Colonoscopy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009378
2. subject has undergone any double-contrast barium enema, virtual (ct-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
Descripción

Double contrast barium enema | Virtual CT colonoscopy | Flexible sigmoidoscopy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0412118
UMLS CUI [2]
C1635173
UMLS CUI [3]
C0016234
3. subject has had a positive fecal occult blood test or fit within the previous six (6) months.
Descripción

Fecal occult blood test Positive | Fecal Immunochemical Test Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201811
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C2700166
UMLS CUI [2,2]
C1514241
4. subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
Descripción

Condition Study Subject Participation Status Excluded | Study Subject Ineligible Colonoscopy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C1512714
UMLS CUI [2,3]
C0009378
5. subject has a history of colorectal cancer or advanced adenoma.
Descripción

Colorectal Carcinoma | Adenoma Advanced

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C0001430
UMLS CUI [2,2]
C0205179
6. subject has a history of aerodigestive tract cancer
Descripción

Upper Aerodigestive Tract Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0887900
7. subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
Descripción

Colorectal resection | Etiology Except Diverticulosis of sigmoid colon

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0810152
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0012818
8. subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (blood on toilet paper, after wiping, does not constitute rectal bleeding)
Descripción

Rectal hemorrhage | Hematochezia | Melena

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0267596
UMLS CUI [2]
C0018932
UMLS CUI [3]
C0025222
9. subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
Descripción

High risk of Colorectal Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0009402
inflammatory bowel disease (ibd) including chronic ulcerative colitis (cuc) and crohn's disease.
Descripción

Inflammatory Bowel Disease | Chronic ulcerative colitis | Crohn Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C2919828
UMLS CUI [3]
C0010346
2 first-degree relatives who have been diagnosed with colon cancer. (note: first-degree relatives include parents, siblings and offspring).
Descripción

Colon Carcinoma First Degree Relative Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0699790
UMLS CUI [1,2]
C1517194
UMLS CUI [1,3]
C1265611
one first-degree relative with crc diagnosed before the age of 60.
Descripción

Colorectal Carcinoma First Degree Relative | Age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C1517194
UMLS CUI [2]
C0001779
10. subject has a family history of:
Descripción

Family history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0241889
familial adenomatous polyposis (also referred to as "fap", including attenuated fap).
Descripción

Adenomatous Polyposis Coli | FAMILIAL ADENOMATOUS POLYPOSIS, ATTENUATED

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032580
UMLS CUI [2]
C2674616
hereditary non-polyposis colorectal cancer syndrome (also referred to as "hnpcc" or "lynch syndrome").
Descripción

Hereditary Nonpolyposis Colorectal Cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1333990
other hereditary cancer syndromes including but are not limited to peutz-jeghers syndrome, myh-associated polyposis (map), gardner's syndrome, turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, cronkhite-canada syndrome, neurofibromatosis and familial hyperplastic polyposis.
Descripción

Neoplastic Syndromes, Hereditary | Peutz-Jeghers Syndrome | Adenomatous Polyposis Coli | Gardner Syndrome | Turcot syndrome | Hamartoma Syndrome, Multiple | Juvenile polyposis syndrome | Cronkhite-Canada Syndrome | Neurofibromatoses | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027672
UMLS CUI [2]
C0031269
UMLS CUI [3]
C0032580
UMLS CUI [4]
C0017097
UMLS CUI [5]
C0265325
UMLS CUI [6]
C0018553
UMLS CUI [7]
C0345893
UMLS CUI [8]
C0282207
UMLS CUI [9]
C0162678
UMLS CUI [10]
C3846158
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Similar models

Eligibility Colorectal Cancer Screening NCT02419716

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Cologuard Tests Colorectal cancer screening
Item
1. subject has been prescribed cologuard for colorectal cancer screening
boolean
C4528851 (UMLS CUI [1,1])
C0281185 (UMLS CUI [1,2])
Average Risk Colorectal Carcinoma
Item
2. subject is at average risk for development of colorectal cancer
boolean
C1510992 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
Age
Item
3. subject is 50 years or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
4. subject willing and able to sign informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Colonoscopy
Item
1. subject had a colonoscopy in the previous 9 years
boolean
C0009378 (UMLS CUI [1])
Double contrast barium enema | Virtual CT colonoscopy | Flexible sigmoidoscopy
Item
2. subject has undergone any double-contrast barium enema, virtual (ct-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years.
boolean
C0412118 (UMLS CUI [1])
C1635173 (UMLS CUI [2])
C0016234 (UMLS CUI [3])
Fecal occult blood test Positive | Fecal Immunochemical Test Positive
Item
3. subject has had a positive fecal occult blood test or fit within the previous six (6) months.
boolean
C0201811 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C2700166 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Condition Study Subject Participation Status Excluded | Study Subject Ineligible Colonoscopy
Item
4. subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy).
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0681850 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
C0009378 (UMLS CUI [2,3])
Colorectal Carcinoma | Adenoma Advanced
Item
5. subject has a history of colorectal cancer or advanced adenoma.
boolean
C0009402 (UMLS CUI [1])
C0001430 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Upper Aerodigestive Tract Neoplasms
Item
6. subject has a history of aerodigestive tract cancer
boolean
C0887900 (UMLS CUI [1])
Colorectal resection | Etiology Except Diverticulosis of sigmoid colon
Item
7. subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease
boolean
C0810152 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0012818 (UMLS CUI [2,3])
Rectal hemorrhage | Hematochezia | Melena
Item
8. subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (blood on toilet paper, after wiping, does not constitute rectal bleeding)
boolean
C0267596 (UMLS CUI [1])
C0018932 (UMLS CUI [2])
C0025222 (UMLS CUI [3])
High risk of Colorectal Carcinoma
Item
9. subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer:
boolean
C0332167 (UMLS CUI [1,1])
C0009402 (UMLS CUI [1,2])
Inflammatory Bowel Disease | Chronic ulcerative colitis | Crohn Disease
Item
inflammatory bowel disease (ibd) including chronic ulcerative colitis (cuc) and crohn's disease.
boolean
C0021390 (UMLS CUI [1])
C2919828 (UMLS CUI [2])
C0010346 (UMLS CUI [3])
Colon Carcinoma First Degree Relative Quantity
Item
2 first-degree relatives who have been diagnosed with colon cancer. (note: first-degree relatives include parents, siblings and offspring).
boolean
C0699790 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Colorectal Carcinoma First Degree Relative | Age
Item
one first-degree relative with crc diagnosed before the age of 60.
boolean
C0009402 (UMLS CUI [1,1])
C1517194 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
Family history
Item
10. subject has a family history of:
boolean
C0241889 (UMLS CUI [1])
Adenomatous Polyposis Coli | FAMILIAL ADENOMATOUS POLYPOSIS, ATTENUATED
Item
familial adenomatous polyposis (also referred to as "fap", including attenuated fap).
boolean
C0032580 (UMLS CUI [1])
C2674616 (UMLS CUI [2])
Hereditary Nonpolyposis Colorectal Cancer
Item
hereditary non-polyposis colorectal cancer syndrome (also referred to as "hnpcc" or "lynch syndrome").
boolean
C1333990 (UMLS CUI [1])
Neoplastic Syndromes, Hereditary | Peutz-Jeghers Syndrome | Adenomatous Polyposis Coli | Gardner Syndrome | Turcot syndrome | Hamartoma Syndrome, Multiple | Juvenile polyposis syndrome | Cronkhite-Canada Syndrome | Neurofibromatoses | Other Coding
Item
other hereditary cancer syndromes including but are not limited to peutz-jeghers syndrome, myh-associated polyposis (map), gardner's syndrome, turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, cronkhite-canada syndrome, neurofibromatosis and familial hyperplastic polyposis.
boolean
C0027672 (UMLS CUI [1])
C0031269 (UMLS CUI [2])
C0032580 (UMLS CUI [3])
C0017097 (UMLS CUI [4])
C0265325 (UMLS CUI [5])
C0018553 (UMLS CUI [6])
C0345893 (UMLS CUI [7])
C0282207 (UMLS CUI [8])
C0162678 (UMLS CUI [9])
C3846158 (UMLS CUI [10])
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