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Completed

NCT Number: NCT02289053

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.

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Key information

Conditions

Colorectal Cancer Adenomatous Polyp of Colon Colon Polyps Colonic Diseases Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

40 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2014
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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