NCT00164944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
748

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

12.3 years

First QC Date

September 9, 2005

Last Update Submit

April 20, 2017

Conditions

Keywords

ColonoscopyFirst degree relatives

Outcome Measures

Primary Outcomes (1)

  • To find the prevalence of adenomas and advanced neoplasms of the first degree relatives

    7 years

Study Arms (2)

FDR of CRC patient

First degree relatives of patients having CRC

Procedure: Colonoscopy

FDR of normal colonoscopy

First degree relatives of patients having normal colonoscopy

Procedure: Colonoscopy

Interventions

ColonoscopyPROCEDURE

To determine the adenomas during colonoscopy

FDR of CRC patient

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

First degree relatives of patients having CRC or patient having normal colonoscopy

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Prince of Wales Hospital

Hong Kong (sar), China

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • James Y Lau, MD

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2016

Study Completion

April 6, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations