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Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Jaeil Kim, Asan Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Jaeil Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01428752
First received: September 2, 2011
Last updated: September 8, 2011
Last verified: September 2011
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Purpose
Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer are controversial. The aim of this study was to prospectively define the prevalence of colorectal adenoma 30- to 49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to compare the data with controls.
Design: Single-center prospective study
| Condition |
|---|
| Colorectal Neoplasms |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Jaeil Kim, Asan Medical Center:
Primary Outcome Measures:
- prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ]
Secondary Outcome Measures:
- prevalence of advanced adenoma [ Time Frame: First screening colonoscopy ]
- Any adenoma ≥10 mm
- Any villous component
- High-grade dysplasia
Biospecimen Retention: Samples Without DNA
whole blood and serum Colorectal polyp/cancer tissue
| Estimated Enrollment: | 1000 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer
|
Detailed Description:
Colorectal cancer screening is recommended for average-risk persons beginning at age 50. A family history of colorectal cancer is recognized as a risk factor for colorectal adenoma. However, the strength of this association is uncertain. Current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer have proved controversial. The conflicting recommendations are partly attributable to the lack of data about the prevalence of CRC and adenomas among 30- to 49-year-old individuals with a first relative history of colorectal cancer. This prospective study will quantify the prevalence of adenomas (any size) and advanced adenomas among 30- to 49-year-old individuals undergoing their first screening colonoscopy because of a first relative history of colorectal cancer and compare the data with controls(asymptomatic subjects without a first relative history of colorectal cancer).
Eligibility| Ages Eligible for Study: | 30 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
30- to 49-year-old asymptomatic subjects undergoing first screening colonoscopy because of a first relative history of colorectal cancer
Criteria
Inclusion Criteria:
- 30- to 49-year-old asymptomatic subjects
- First relative history of colorectal cancer
Exclusion Criteria:
- previous colonoscopy for any reason
- personal history of colorectal adenomas or CRC
- history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
- documented history of occult GI bleeding, lower gastrointestinal tract bleeding not attributable to hemorrhoid, or
- iron deficiency anemia
- unexplained weight loss of >10% of the body weight in the 6 months before colonoscopy
- incomplete examination of entire colon
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01428752
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428752
Contacts
| Contact: JAEIL KIM, M.D | 82230105673 | pianojaeil@nate.com | |
| Contact: KYUNG-JO KIM, M.D | 82230103196 | capsulendos@gmail.com |
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Kyung-Jo Kim, M.D 82230103196 capsulendos@gmail.com | |
| Contact: Jaeil Kim, M.D 82230105673 pianojaeil@nate.com | |
Sponsors and Collaborators
Asan Medical Center
Investigators
| Study Director: | Kyung-Jo Kim, M.D | Department of Gastroenterology, Asan Medical Center |
More Information
| Responsible Party: | Jaeil Kim, Clinical Assistant Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01428752 History of Changes |
| Other Study ID Numbers: |
ADENOMA 30-49 YO |
| Study First Received: | September 2, 2011 |
| Last Updated: | September 8, 2011 |
Keywords provided by Jaeil Kim, Asan Medical Center:
|
colonoscopy colorectal neoplasms screening family history |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Adenoma Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on August 16, 2017