An observational study in Colorectal Cancer, Colon Polyps and Adenomatous Polyp of Colon, sponsored by University of Michigan. Completed at 6 sites in United States. Open to participants aged 40 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by University of Michigan · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 1,623 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.
Exclusion Criteria:
Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group.
Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group.
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.
Time frame: Data analysis will begin September 2014 for a duration of three months.
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.
Time frame: 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.
Time frame: Data analysis will begin September 2014 for a duration of three months.
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.
Time frame: Data analysis will begin September 2014 for a duration of three months.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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