Adenoma Clinical Trial
— ANOfficial title:
A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study)
NCT number | NCT01593098 |
Other study ID # | AN study |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 8, 2010 |
Est. completion date | December 2025 |
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
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 - Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination |
Country | Name | City | State |
---|---|---|---|
China | Endoscopy Centre,Alice Ho Miu Ling Nethersole Hospital & Tai Po Hospital | Hong Kong | |
Hong Kong | Endocopy Center, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
China, Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of adenoma and CRC | 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) | 30 days | |
Secondary | Rate of advanced neoplasms depending on age of index case | same as primary outcome | 30 days | |
Secondary | Rate of advanced neoplasms depending on site of neoplasm | same as primary outcome | 30 days | |
Secondary | Differences in genetic profile between siblings of patients with advanced neoplasm and controls | same as primary outcome | 30 days |
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