Clinical trial NCT00164944: Screening for Colorectal Neoplasm in First Degree Relatives of the Affected
Official title: Colonoscopic Screening in First-degree Relatives of Hong Kong Chinese Patients With Sporadic Colorectal Cancer: a Cohort Study With Case Control Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Screening
Keywords: Colonoscopy
First degree relatives
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 748
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First degree relatives of patients having CRC or patient having normal colonoscopy

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.

Eligibility criteria: 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).

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

Primary outcomes:
measure: To find the prevalence of adenomas and advanced neoplasms of the first degree relatives
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong (SAR)
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: James Y Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ng SC, Lau JY, Chan FK, Suen BY, Leung WK, Tse YK, Ng SS, Lee JF, To KF, Wu JC, Sung JJ. Increased risk of advanced neoplasms among asymptomatic siblings of patients with colorectal cancer. Gastroenterology. 2013 Mar;144(3):544-50. doi: 10.1053/j.gastro.2012.11.011. Epub 2012 Nov 13.