Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
- Conditions
- Colorectal Cancer
- Registration Number
- NCT02037646
- Lead Sponsor
- University of Malaya
- Brief Summary
The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
- Detailed Description
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- Adults aged 50 years and above
- Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
- Personal history of colorectal tumour or cancer
- Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to diagnosis of advanced colorectal neoplasms 40-90 days from the time of enrolment Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
- Secondary Outcome Measures
Name Time Method Analysis of screening costs Up to 90 days following enrolment Total costs incurred as a result of the screening process
Patient anxiety levels Up to 90 days after enrolment As measured by the Hospital Anxiety and Depression Scale (HADS)
Related Research Topics
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Trial Locations
- Locations (1)
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
University of Malaya Medical Centre🇲🇾Kuala Lumpur, Malaysia