A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01593098
First received: May 1, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

To prospectively determine the prevalence of colorectal neoplasia in siblings of Hong Kong Chinese patients with advanced neoplasm compared with a sex and age-matched control population. To determine the molecular alteration profiles of colonic adenomas in siblings of patients with advanced neoplasm


Condition
Adenoma
CRC

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study)

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Prevalence of adenoma and CRC [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    With informed consents, experienced colonoscopists will perform colonoscopy under intravenous sedation During colonoscopic examination, endoscopists are instructed to remove all raised lesions. The size, location and morphologic feature of each raised lesion will be recorded. The size is measured again an open biopsy forceps (6mm apart). To avoid observer bias, colonoscopists and pathologists will be blinded from patient's details regarding family history of CRC or advanced neoplasms. Our group performed the first screening study among average risk Hong Kong Chinese in the locality (28)


Secondary Outcome Measures:
  • Rate of advanced neoplasms depending on age of index case [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    same as primary outcome

  • Rate of advanced neoplasms depending on site of neoplasm [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    same as primary outcome

  • Differences in genetic profile between siblings of patients with advanced neoplasm and controls [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    same as primary outcome


Biospecimen Retention:   Samples With DNA

colonic biopsies, blood, stool


Estimated Enrollment: 511
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
case
Siblings (age >40 and <70) of individuals diagnosed with advanced neoplasm on screening colonoscopy. Advanced neoplasm is defined as adenomas≥10mm size, >25% villous features, severe dysplasia or carcinoma-in-situ
control
Siblings (age >40 and <70) of individuals diagnosed with no polyp on screening colonoscopy who is age and sex matched to case.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

residence of Hong Kong siblings with colonoscopy done Siblings of Patients with Advanced Neoplasm (case) siblings of patients with normal colonoscopy (control)

Criteria

Inclusion Criteria:

  • (case) Siblings (age > 40 and < 70) of individuals diagnosed with advanced neoplasm on screening colonoscopy. Advanced neoplasm is defined as adenomas ≥ 10mm size, >25% villous features, severe dysplasia or carcinoma-in-situ
  • (control) Siblings of patients with negative findings on colonoscopy identified during the same study period, who are of the same age group as the studied cohort.

Exclusion Criteria:

  • A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria [Table 3].
  • Known Familial Adenomatous Polyposis (FAP) syndrome
  • Patients and siblings with known inflammatory bowel disease
  • Siblings that have undergone colonoscopy examinations in the past 5 years
  • Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593098

Contacts
Contact: Siew C Ng, PhD (852)26373509 siewchienng@cuhk.edu.hk
Contact: BingYee Suen, BHSc (853)26322931 suenbingyee@cuhk.edu.hk

Locations
China
Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital Recruiting
Hong Kong, China
Contact: James Lau, MD    852 2632 2931    jameslau@cuhk.edu.hk   
Endocopy Center, Prince of Wales Hospital Recruiting
Hong Kong SAR, China
Contact: Justin C Wu, MD    852 2632 3307    justinwu@cuhk.edu.hk   
Sub-Investigator: James Y Lau, MD         
Sub-Investigator: Joseph J Sung, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Francis KL Chan, Professor of Medicine, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01593098     History of Changes
Other Study ID Numbers: AN study
Study First Received: May 1, 2012
Last Updated: April 9, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
siblings
advanced neoplasm
mRNA
TaqMan microRNA expression assays

Additional relevant MeSH terms:
Adenoma
Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014