CRC Screening for High Risk Population in HK
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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. . 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.
    

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

        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.

      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

        1. 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

        2. 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.
    

Intervention name(s): Fecal immunochemical test (FIT)
Intervention type(s): Diagnostic Test
Intervention description(s): Annual fecal immunochemical test (FIT) for selected high risk individuals to undergo CRC screening. And colonoscopy for those with FIT positive result
Intervention model: Single Group Assignment
Intervention model description: selected high risk group of individuals for CRC screening by using FIT
Masking: None (Open Label)
Primary purpose: Other