Colorectal Cancer Clinical Trial
Official title:
Colorectal Cancer (CRC) Screening in Hong Kong: an Analysis on Acceptability, Compliance, Diagnostic Accuracy and Clinical Outcomes
NCT number | NCT03597204 |
Other study ID # | CEHR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 7, 2015 |
Est. completion date | December 31, 2017 |
Verified date | July 2018 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Colorectal neoplasm in Asia is now increasingly common and is rising in an alarming manner in
Hong Kong. Population-based screening for colorectal cancer (CRC) should be implemented. With
the establishment of the CUHK JC Bowel Cancer Education Centre in 2008, about 10,000
asymptomatic subjects aged 50-70 years have completed screening by either faeca
immunochemical test (FIT)or colonoscopy till December 2012. From 2013 onwards, the centre
invites subjects aged 40-70 years with risk factors for CRC to undergo screening by FIT on a
yearly basis. If FIT result is positive, according to local practice, they will be offered a
routine colonoscopy as they will be treated as symptomatic. Currently, about 2,500 subjects
have received CRC screening in this new project. There will be 2,500 subjects more to be
recruited to this till 31 December 2017. The investigators would like to carry out a
prospective cohort study of these 2,500 subjects and also retrospectively review the cohort
of 12,500 subjects who received CRC screening in the CUHK JC Bowel Cancer Education Centre.
The present study aims to:
1. . Evaluate the knowledge, attitude, perception, practice, perceived obstacles and
changes in choice of CRC screening among the screening participants;
2. . Assess the levels of compliance across time among those who joined the screening
programme, according to different subject characteristics;
3. . Explore the diagnostic accuracy of faecal immunochemical tests among subjects with
different characteristics;
4. . Evaluate the risk factors for colorectal neoplasia and if applicable, devise and
validate a risk scoring system for prediction of neoplasia in different colon sites;
5. . Evaluate the association between bowel preparation, colonoscopy withdrawal time and
adenoma detection rate among those who received colonoscopy;
6. . Validation of the existing risk scoring systems for colorectal neoplasia from the
literature, based on findings from subjects who received colonoscopy.
7. . Explore potential associations among colorectal neoplasia detected in different colon
sites.
Status | Completed |
Enrollment | 15000 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: Retrospective cohort 1. Subjects received CRC screening in CUHK JC Bowel Cancer Education Centre from 2008 up to 30 Sept 2015 Prospective cohort 1. Subjects aged 40-75 who were asymptomatic of CRC from CUHK JC Bowel Cancer Education Centre 2. Informed consent available 3. Identified as having risk factors for CRC (defined as having a Asia Pacific Colorectal Screening (APCS) score 4-7; the presence of diabetes; body mass index =25 kg/m2; or the presence of family history of CRC) Exclusion Criteria: 1. Subject with any lower gastrointestinal (GI) symptoms (including lower GI bleeding, change in bowel habit, anemia and weight loss) 2. Prior history of colonic diseases that might increase the risk of colorectal cancer (including colorectal neoplasm, inflammatory bowel disease) 3. Examination of the colon (e.g. colonoscopy, barium enema or CT/MR of the colon) within the past 5 years 4. History of colorectal surgery in the past 5. Any contraindication for colonoscopy |
Country | Name | City | State |
---|---|---|---|
Hong Kong | CUHK Jockey Club Bowel Cancer Education Centre | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer | The diagnostic accuracy of faecal immunochemical test in the selected high risk individuals. The number of subjects diagnosed colonic adenoma, advanced adenoma or cancer will be divided by the total number of selected high risk subjects received fecal immunochemical test | Up to three years |
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