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| ID | Type | Description | Link |
|---|---|---|---|
| 1K24DK084208 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Participants are recruited from the endoscopy units of the participating study sites prior to their colonoscopy procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Philip Schoenfeld, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States | ||
| Ann Arbor VA Healthcare System |
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| 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. |
| Ann Arbor |
| Michigan |
| 48105 |
| United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| John D. Dingell VA Medical Center | Detroit | Michigan | 48201 | United States |
| Huron Gastro | Ypsilanti | Michigan | 48197 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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