Clinical trial NCT01428752: Study of Prevalence of Colorectal Adenoma in 30- to 49-year-old Subjects With a Family History of Colorectal Cancer
Official title: Prevalence of Colorectal Adenoma in 30- to 49-year-old Asymptomatic Subjects With a First Relative History of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Keywords: colonoscopy
colorectal neoplasms
screening
family history
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility 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

Primary outcomes:
measure: prevalence of colorectal adenoma(any size)
timeFrame: First screening colonoscopy
Secondary outcomes:
measure: prevalence of advanced adenoma
timeFrame: First screening colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Department of Gastroenterology, Asan Medical Center
name: Kyung-Jo Kim, M.D
role: STUDY_DIRECTOR
References: