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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Colon Polyps, Adenomatous Polyp of Colon

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive Family History<br>Eligible participants with a family history of colorectal cancer or polyps will be grouped into the subjects group. | |
| Average Risk Patients<br>Eligible participants without a family history of colorectal cancer or polyps will be grouped into the control group. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer