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

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ClinicalTrials.gov Identifier: NCT01428752
Recruitment Status : Unknown
Verified September 2011 by Jaeil Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 5, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
Jaeil Kim, Asan Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease
Colorectal Neoplasms

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 Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
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
Study Start Date : September 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Family history
30- to 49-year-old asymptomatic subjects with a first relative history of colorectal cancer


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of colorectal adenoma(any size) [ Time Frame: First screening colonoscopy ]

Secondary Outcome Measures :
  1. prevalence of advanced adenoma [ Time Frame: First screening colonoscopy ]
    1. Any adenoma ≥10 mm
    2. Any villous component
    3. High-grade dysplasia


Biospecimen Retention:   Samples Without DNA
whole blood and serum Colorectal polyp/cancer tissue

Eligibility Criteria
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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: September 9, 2011
Last Verified: September 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