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

NCT02289053 | Completed

• 2 other identifiers: K24-DK1K24DK084208
• Study Type: observational
• Target: 1,623
• Locations: 1 country
• Sites: 6

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.

Conditions

Colorectal Cancer; Colon Polyps; Adenomatous Polyp of Colon

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of advanced adenomas among 40-49 year old individuals with and without a family history of colorectal cancer

  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.

  Data analysis will begin September 2014 for a duration of three months.

Secondary Outcomes (2)

• Absolute prevalence of advanced adenomas in 40-49 year olds with a family history of colorectal cancer

  Data analysis will begin September 2014 for a duration of three months.

• Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps

  Data analysis will begin September 2014 for a duration of three months.

Other Outcomes (1)

• Risk factors associated with the presence of advanced adenomas

  Data analysis will begin September 2014 for a duration of three months.

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.

You may qualify if:

• year old asymptomatic men and women referred for colorectal cancer screening with a family history of CRC in a first degree relative;
• year old asymptomatic men and women referred for colorectal cancer screening with a family history of polyps in a first degree relative;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Ann Arbor VA Healthcare System

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

John D. Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

Huron Gastro

Ypsilanti, Michigan, 48197, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip Schoenfeld, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: November 13, 2014
• Study Start: April 1, 2006
• Primary Completion: June 30, 2014
• Study Completion: June 30, 2014
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (6)