CClinicalTrials.gg
Status unknownNCT01428752Updated Sep 9, 2011

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

An observational study in Colorectal Neoplasms, sponsored by Asan Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 30 Years to 49 Years. Per ClinicalTrials.gov, last updated 2011-09-09.

Sponsored by Asan Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
30 Years to 49 Years
Sex
All
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Study 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

Read the 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).

02

Conditions studied

  • Colorectal Neoplasms

Keywords

  • colonoscopy
  • colorectal neoplasms
  • screening
  • family history
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 49 Years
Sexes eligible
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

Inclusion criteria

  • 30- to 49-year-old asymptomatic subjects
  • First relative history of colorectal cancer

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Family history

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

06

What researchers measure

Primary outcomes

  1. prevalence of colorectal adenoma(any size)

    Time frame: First screening colonoscopy

Secondary outcomes

  1. prevalence of advanced adenoma

    1. Any adenoma ≥10 mm 2. Any villous component 3. High-grade dysplasia

    Time frame: First screening colonoscopy

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01428752
Lead sponsor
Asan Medical Center
Responsible party
Jaeil Kim (Clinical Assistant Professor, Asan Medical Center) — Principal investigator
First posted
Sep 5, 2011
Start date
Sep 2011
Primary completion
Sep 2014 (estimated)
Completion
Sep 2014 (estimated)
Last update
Sep 9, 2011

Study contacts

JAEIL KIM, M.D
Contact
pianojaeil@nate.com
82230105673
KYUNG-JO KIM, M.D
Contact
capsulendos@gmail.com
82230103196
Kyung-Jo Kim, M.D
study director · Department of Gastroenterology, Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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