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Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

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ClinicalTrials.gov Identifier: NCT02289053
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Philip Schoenfeld, University of Michigan

Brief Summary:
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.

Condition or disease
Colorectal Cancer Colon Polyps Adenomatous Polyp of Colon

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Study Type : Observational
Actual Enrollment : 1623 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer
Actual Study Start Date : April 1, 2006
Actual Primary Completion Date : June 30, 2014
Actual Study Completion Date : June 30, 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Positive Family History
Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group.
Average Risk Patients
Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group.



Primary Outcome Measures :
  1. Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.


Secondary Outcome Measures :
  1. Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.

  2. Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.


Other Outcome Measures:
  1. Risk factors associated with the presence of advanced adenomas [ Time Frame: Data analysis will begin September 2014 for a duration of three months. ]
    Logistic regression will be used to determine if specific risk factors are associated with the risk of adenomas in 40-49 year old individuals. Data will be collected from patient surveys and medical records.



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Ages Eligible for Study:   40 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.
Criteria

Inclusion Criteria:

  • 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
  • 40-49 year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
  • 40-49 year old men and women without a family history of CRC or polyps in a first degree relative who are referred for colonoscopy to evaluate scant hematochezia characterized as red blood on toilet tissue after wiping or small droplets of blood on stool or in toilet water after evacuating stool, abdominal discomfort or altered bowel habits characterized as constipation or diarrhea.

Exclusion Criteria:

  • Personal history of iron deficiency anemia within six months of referral;
  • Personal history of iron deficiency without anemia within six months of referral;
  • Personal history of (+) FOBT within one year of referral;
  • Personal history of previous colonoscopy or barium enema within the past 10 years;
  • Personal history of previous flexible sigmoidoscopy in the past 5 years;
  • Personal history of adenoma, colorectal cancer, inflammatory bowel disease, HNPCC, or familial adenomatous polyposis (FAP);
  • Unintentional weight loss > 10 lbs within the previous six months;
  • Individuals with family history of CRC AND scant hematochezia;
  • Inability to speak and read English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289053


Locations
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United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Michigan
Ann Arbor VA Healthcare System
Ann Arbor, Michigan, United States, 48105
University of Michigan
Ann Arbor, Michigan, United States, 48109
John D. Dingell VA Medical Center
Detroit, Michigan, United States, 48201
Huron Gastro
Ypsilanti, Michigan, United States, 48197
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Philip Schoenfeld, MD University of Michigan

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Responsible Party: Philip Schoenfeld, Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT02289053     History of Changes
Other Study ID Numbers: K24-DK
1K24DK084208 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Philip Schoenfeld, University of Michigan:
Colorectal Cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Polyps
Adenoma
Adenomatous Polyps
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Intestinal Polyps