Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer

NCT ID: NCT01428752

Last Updated: 2011-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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).

Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Family history

30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jaeil Kim

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung-Jo Kim, M.D

Role: STUDY_DIRECTOR

Department of Gastroenterology, Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JAEIL KIM, M.D

Role: CONTACT

82230105673

KYUNG-JO KIM, M.D

Role: CONTACT

82230103196

Facility Contacts

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Kyung-Jo Kim, M.D

Role: primary

82230103196

Jaeil Kim, M.D

Role: backup

82230105673

Other Identifiers

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ADENOMA 30-49 YO

Identifier Type: -

Identifier Source: org_study_id

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