Colonoscopy Screening in Siblings of Patients With Advanced Neoplasm: A Concurrent Case-Control Study (Sibling AN Study)
This study is currently recruiting participants.
Verified May 2012 by Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Francis KL Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01593098
First received: May 1, 2012
Last updated: May 4, 2012
Last verified: May 2012
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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 |
|---|
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Advanced Neoplasm MicroRNA-21 (miR-21) and miR-92 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Colonoscopy Screening in Siblings of Patients With Advanced Neoplasm: A Concurrent Case-Control Study (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 Prevalence of adenoma and CRC [ Time Frame: one year ] [ 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: 1year ] [ Designated as safety issue: No ]same as primary outcome
- Rate of advanced neoplasms depending on site of neoplasm [ Time Frame: one year ] [ Designated as safety issue: No ]same as primary outcome
- Differences in genetic profile between siblings of patients with advanced neoplasm and controls [ Time Frame: 1 year ] [ Designated as safety issue: No ]same as primary outcome
- Detection of miRNA 21 and miRNA-92 of stool will be performed [ Time Frame: 3 years ] [ Designated as safety issue: No ]Stool samples will be collected prior to colonoscopy, and every 6 monthly for up to 3 years after polyp removal. Total RNA will be extracted from 0.2 to 0.3g stool, plasma and from biopsy tissues by TriZol LS agent and Qiagen microRNA purification kit. Detection of miRNA 21 and miRNA-92 will be performed using TaqMan microRNA expression assays. Absolute value of microRNA molecules will be evaluated using standard curves from dilution series of chemically synthesized RNA. All Polymerase chain reactions will be duplicated to ensure consistency and reproducibility of results.
Biospecimen Retention: Samples With DNA
colonic biopsies, blood, stool
| Estimated Enrollment: | 636 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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
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control
Siblings (age >40 and <70) of individuals diagnosed with no polyp on screening colonoscopy.
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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
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: | May 4, 2012 |
| 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:
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Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013