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A Prospective Study Into the Risk of Colorectal Neoplasms in Individuals With a Family History of Advanced Adenomas (Sibling AN Study) (AN)
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| ClinicalTrials.gov Identifier: NCT01593098 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2012
Last Update Posted : December 13, 2018
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Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
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Brief Summary:
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 or disease |
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| Adenoma CRC |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| 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) |
| Actual Study Start Date : | June 8, 2010 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Colorectal Cancer
| Group/Cohort |
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Exposed siblings
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
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unexposed siblings
Siblings (age >40 and <70) of individuals diagnosed with no polyp on screening colonoscopy who is age and sex matched to case.
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Primary Outcome Measures :
- Prevalence of adenoma and CRC [ Time Frame: 30 days ]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 ]same as primary outcome
- Rate of advanced neoplasms depending on site of neoplasm [ Time Frame: 30 days ]same as primary outcome
- Differences in genetic profile between siblings of patients with advanced neoplasm and controls [ Time Frame: 30 days ]same as primary outcome
Biospecimen Retention: Samples With DNA
colonic biopsies, blood, stool
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| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
- Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| 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 | |
| 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 | |
Sponsors and Collaborators
Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| First Posted: | May 7, 2012 Key Record Dates |
| Last Update Posted: | December 13, 2018 |
| Last Verified: | December 2018 |
Keywords provided by Francis KL Chan, Chinese University of Hong Kong:
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siblings advanced neoplasm mRNA TaqMan microRNA expression assays |
Additional relevant MeSH terms:
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Neoplasms Adenoma 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 |