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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289053
• Other study ID #: K24-DK
• Secondary ID: 1K24DK084208
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: May 12, 2017
• Start date: April 1, 2006
• Est. completion date: June 30, 2014

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1623
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyp of Colon
• Adenomatous Polyps
• Colon Polyps
• Colonic Neoplasms
• Colonic Polyps
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Locations

Country	Name	City	State
United States	Ann Arbor VA Healthcare System	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	John D. Dingell VA Medical Center	Detroit	Michigan
United States	Durham VA Medical Center	Durham	North Carolina
United States	Huron Gastro	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.
Secondary	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.