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CRC Screening for High Risk Population in HK

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fecal immunochemical test (FIT)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CUHK Jockey Club Bowel Cancer Education Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

fecal immunochemical test (FIT)

Arm Description

Annual fecal immunochemical test (FIT) for selected high risk individuals to undergo CRC screening. And colonoscopy for those with FIT positive result

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2018
Last Updated
July 13, 2018
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03597204
Brief Title
CRC Screening for High Risk Population in HK
Official Title
Colorectal Cancer (CRC) Screening in Hong Kong: an Analysis on Acceptability, Compliance, Diagnostic Accuracy and Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 7, 2015 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: . Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants; . Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics; . Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics; . 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; . Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy; . Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy. . Explore potential associations among colorectal neoplasia detected in different colon sites.
Detailed Description
BACKGROUND Colorectal neoplasm in Asia is not less common compared to that of the Western population and screening for colorectal cancer (CRC) should be implemented. In the Asia Pacific Consensus for Colorectal Cancer, Fecal Occult Blood Test (FOBT) was recommended as the preferred test in resource limited areas in Asia. Yet, the preference of Asian in the options for CRC screening might be different. In a recent study from Hong Kong, most subjects preferred to use colonoscopy instead of stool tests as the screening tool. A study from Asia showed that fecal immunochemical test (FIT) might be preferred because it obviates the need for dietary control. Educating the public about different options available is an important method to change the health seeking behavior of subjects. The CUHK JC Bowel Cancer Education Centre was established in 2008 with full funding from the Hong Kong Jockey Club Charities Trust. About 10,000 subjects received CRC screening by either FIT or colonoscopy till 31 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, a total of about 2,500 asymptomatic subjects have received CRC screening in this new project and the Centre will continue to recruit 2,500 subjects more till 31 December 2017. To inform future screening policy for implementation of population-based screening, it is important to explore the different aspects of this community-based CRC screening programme which include various indicators of programmatic performance. STUDY AIMS Evaluate the knowledge, attitude, perception, practice, perceived obstacles and changes in choice of CRC screening among the screening participants; Assess the levels of compliance across time among those who joined the screening programme, according to different subject characteristics; Explore the diagnostic accuracy of faecal immunochemical tests among subjects with different characteristics; 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; Evaluate the association between bowel preparation, colonoscopy withdrawal time and adenoma detection rate among those who received colonoscopy; Validation of the existing risk scoring systems for colorectal neoplasia from the literature, based on findings from subjects who received colonoscopy. Explore potential associations among colorectal neoplasia detected in different colon sites. METHODOLOGY Retrospective cohort Demographic data, health behavior information and clinical outcomes of subjects who received CRC screening in CUHK Bowel Cancer Education Centre from December 2008 to Sept 2015 will be retrospectively reviewed without consent and analyzed. Prospective cohort Study subjects will be invited to join the study via routine health talk of a CRC screening program organized by CUHK JC Bowel Cancer Education Centre Each eligible subject completed a self-administered survey, which consists of sociodemographic information, family history of CRC for a first-degree relative, past medical history, and use of chronic medications. The completeness of questionnaires is checked afterwards. Trained volunteers assist survey completion for the relatively illiterate participants. The investigators used a quantitative FIT (OC Sensor). Participants received information on procedures for collecting the FIT samples at home, according to the manufacturer's instructions. They are requested to return their collection tubes containing faecal specimens to the centre 6 days within the stool collection. For those with negative FIT, they will be reminded to continue the FIT screening on a yearly basis till 2018. For those subjects with FIT positive findings, according to local practice, they will be offered a routine colonoscopy as they will be treated as symptomatic. Subjects who undergo colonoscopy may receive a phone-call follow up every year for the period of the study to monitor the clinical outcome of the subject. Subjects develop symptoms suggestive of colorectal neoplasm will be worked up by the original team of investigators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
selected high risk group of individuals for CRC screening by using FIT
Masking
None (Open Label)
Allocation
N/A
Enrollment
15000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fecal immunochemical test (FIT)
Arm Type
Other
Arm Description
Annual fecal immunochemical test (FIT) for selected high risk individuals to undergo CRC screening. And colonoscopy for those with FIT positive result
Intervention Type
Diagnostic Test
Intervention Name(s)
Fecal immunochemical test (FIT)
Intervention Description
Annual fecal immunochemical test (FIT) for selected high risk individuals to undergo CRC screening. And colonoscopy for those with FIT positive result
Primary Outcome Measure Information:
Title
Number of subjects diagnosed colonic adenoma, advanced adenoma or cancer
Description
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
Time Frame
Up to three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph JY Sung, MD, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUHK Jockey Club Bowel Cancer Education Centre
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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CRC Screening for High Risk Population in HK

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