Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 2, 2011 | ||||||||
| Last Updated Date | September 8, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
prevalence of colorectal adenoma(any size) and advanced adenoma [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01428752 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
prevalence of advanced adenoma [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ]
|
||||||||
| Original Secondary Outcome Measures ICMJE |
prevalence of colorectal cancer [ Time Frame: First screening colonoscopy ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer | ||||||||
| Official Title ICMJE | Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer | ||||||||
| Brief Summary | 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 |
||||||||
| 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). |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: whole blood and serum Colorectal polyp/cancer tissue |
||||||||
| 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 |
||||||||
| Condition ICMJE | Colorectal Neoplasms | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | September 2014 | ||||||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 30 Years to 49 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01428752 | ||||||||
| Other Study ID Numbers ICMJE | ADENOMA 30-49 YO | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Jaeil Kim, Asan Medical Center | ||||||||
| Study Sponsor ICMJE | Asan Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Asan Medical Center | ||||||||
| Verification Date | September 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||