Screening for Colorectal Neoplasm in First Degree Relatives of the Affected

NCT ID: NCT00164944

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

748 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2017-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer Screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FDR of CRC patient

First degree relatives of patients having CRC

Colonoscopy

Intervention Type PROCEDURE

To determine the adenomas during colonoscopy

FDR of normal colonoscopy

First degree relatives of patients having normal colonoscopy

Colonoscopy

Intervention Type PROCEDURE

To determine the adenomas during colonoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colonoscopy

To determine the adenomas during colonoscopy

Intervention Type PROCEDURE

Colonoscopy

To determine the adenomas during colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James Yun-wong Lau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James Y Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23159367 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FDR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.