Screening for Colorectal Neoplasm in First Degree Relatives of the Affected

Completed

• Conditions: Colorectal Cancer Screening
• Interventions: Procedure: Colonoscopy

• Registration Number: NCT00164944
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

To determine the prevalence of colorectal neoplasms in first degree relatives of those affected with sporadic colorectal cancer using colonoscopy as a screening tool. The prevalence will be compared to that of a defined matched cohort.

Detailed Description

Colorectal cancer is a second commonest tumor in Hong Kong and the second commonest cause of cancer related death. About 1 in 23 males will develop colorectal cancer in his life time. The disease tends to cluster in families. This may be a combination of factors including shared genes, shared environment or chance. Known familial syndromes occur in only about 5% of cases. The majority is not well understood and labelled sporadic colorectal cancer. The screening strategy in families of subjects with colorectal cancer has not been defined. Colonoscopy is among the most sensitive and specific screening tool for colorectal neoplasm. The current study determines the prevalence of adenomas among first degree relatives of patients diagnosed with colorectal cancer. To quantify risk in this cohort, a case control analysis is used. The prevalence of the cohort is compared to that of a control population. The control group consists of relatives of patients with normal colonoscopic findings during the same study period.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2016-08
• Status Verified: 2017-04
• Study Completion: 2017-04-06
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 748

Inclusion Criteria

• First degree relatives (age >40 and <70) of individuals affected with sporadic colorectal cancer (those not associated with inflammatory bowel disease, familial adenomatous polyposis or HNPCC syndrome).

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Exclusion Criteria

• A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria [Table 5].
• Known Familial Adenomatous Polyposis (FAP) syndrome
• Patients and relatives with known inflammatory bowel disease
• Relatives that have received colonoscopy examinations in the past 5 years [details of colonoscopic examinations will be sought and information on colonic neoplasms recorded]. Those who have had barium enema examinations are eligible for trial inclusion as barium examinations often have low sensitivity and specificity for adenomas (around 70% respectively)
• Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FDR of CRC patient	Colonoscopy	First degree relatives of patients having CRC
FDR of normal colonoscopy	Colonoscopy	First degree relatives of patients having normal colonoscopy

Primary Outcome Measures

Name	Time	Method
To find the prevalence of adenomas and advanced neoplasms of the first degree relatives	7 years

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong (SAR), China