Effectiveness of Fecal Immunnochemical Test and Colonoscopy Screening in Hong Kong

NCT03597204 | Active Not Recruiting DMC

• 1 other identifier: CEHR
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.. Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants;
2. 2.. Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics;
3. 3.. Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics;
4. 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. 5.. Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy;
6. 6.. Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy.
7. 7.. Explore potential associations among colorectal neoplasia detected in different colon sites.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Long-term CRC incidence and mortality and all-cause mortality

  At least 10 years

Study Arms (2)

Fecal immunochemical test (FIT)

ACTIVE COMPARATOR

Annual fecal immunochemical test (FIT) for up to five years and follow-up colonoscopy was arranged for those with FIT positive result

Diagnostic Test: Fecal immunochemical test (FIT)

Colonoscopy

ACTIVE COMPARATOR

Subjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening

Diagnostic Test: Colonoscopy

Interventions

Fecal immunochemical test (FIT) DIAGNOSTIC_TEST

Annual fecal immunochemical test (FIT) for up to five years and follow-up colonoscopy was arranged for those with FIT positive result

Fecal immunochemical test (FIT)

Colonoscopy DIAGNOSTIC_TEST

Subjects in the retrospective cohort were allowed to choose one-off colonoscopy for CRC screening

Colonoscopy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Retrospective cohort
• \. 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)

You may not qualify if:

• Subject with any lower gastrointestinal (GI) symptoms (including lower GI bleeding, change in bowel habit, anemia and weight loss)
• Prior history of colonic diseases that might increase the risk of colorectal cancer (including colorectal neoplasm, inflammatory bowel disease)
• Examination of the colon (e.g. colonoscopy, barium enema or CT/MR of the colon) within the past 5 years
• History of colorectal surgery in the past
• Any contraindication for colonoscopy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

CUHK Jockey Club Bowel Cancer Education Centre

Hong Kong, Hong Kong

Location

Related Publications (1)

• Zhu Z, Lam TYT, Tang RSY, Wong SH, Lui RNS, Ng SSM, Wong SYS, Sung JJY. Triglyceride-glucose index (TyG index) is associated with a higher risk of colorectal adenoma and multiple adenomas in asymptomatic subjects. PLoS One. 2024 Nov 7;19(11):e0310526. doi: 10.1371/journal.pone.0310526. eCollection 2024.

  PMID: 39509387 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joseph JY Sung, MD, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Therapeutics

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 24, 2018
• Study Start: October 7, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

HK (1)