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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenomatous Polyp of Colon; Colon Polyps

• Study Type: Observational
• Enrollment (Actual): 1623

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Ann Arbor VA Healthcare System
    • Detroit, Michigan, United States, 48201
      • John D. Dingell VA Medical Center
    • Ypsilanti, Michigan, United States, 48197
      • Huron Gastro
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute prevalence of advanced adenomas in 40-49 year olds with 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.
Absolute prevalence of advanced adenomas in 40-49 year old individuals with a family history of colorectal polyps	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated with the presence of advanced adenomas	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.	Data analysis will begin September 2014 for a duration of three months.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Philip Schoenfeld, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2006
• Primary Completion (ACTUAL): June 30, 2014
• Study Completion (ACTUAL): June 30, 2014

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (ESTIMATE): November 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Colorectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Intestinal Polyps; Colorectal Neoplasms; Adenoma; Polyps; Colonic Polyps; Adenomatous Polyps
• Other Study ID Numbers: K24-DK; 1K24DK084208 (NIH)