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NCT03597204Active, not recruiting

Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong

Colorectal Cancer (CRC) Screening in Hong Kong: an Analysis on Acceptability, Compliance, Diagnostic Accuracy and Clinical Outcomes

Source: ClinicalTrials.gov · Last updated 23 Jul 2025

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Study type
Interventional
Enrollment
15000 (actual)
First submitted
18 Jun 2018
Start date
7 Oct 2015
Primary completion date
31 Dec 2025
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT03597204

What you commit to

  • Study type: Interventional
  • Participants enrolled: 15000
  • From 7 Oct 2015 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior history of colonic diseases that might increase the risk of colorectal cancer (including colorectal neoplasm, inflammatory bowel disease)

Other illness

  • Subject with any lower gastrointestinal (GI) symptoms (including lower GI bleeding, change in bowel habit, anemia and weight loss)
  • History of colorectal surgery in the past

Other

  • Examination of the colon (e.g. colonoscopy, barium enema or CT/MR of the colon) within the past 5 years
  • Any contraindication for colonoscopy

Who the study is looking for

  • Retrospective cohort
  • 1\. Subjects received CRC screening in CUHK JC Bowel Cancer Education Centre from 2008 up to 30 Sept 2015
  • Prospective cohort
  • Subjects aged 40-75 who were asymptomatic of CRC from CUHK JC Bowel Cancer Education Centre
  • Informed consent available
  • 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)

Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CUHK Jockey Club Bowel Cancer Education Centre
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.