Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
Conditions
Colorectal Cancer
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Intervention
Name: Qualitative fecal immunochemical test Type: Other
Name: Quantitative fecal immunochemical test Type: Other
Name: Colonoscopy Type: Procedure
Name: Cost analysis Type: Other
Name: Anxiety scores Type: Other
Name: Patient satisfaction scores Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adults aged 50 years and above

Exclusion Criteria:

- 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
Location
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Status: Recruiting
Start Date
June 2012
Completion Date
December 2015
Sponsors
University of Malaya
Source
University of Malaya
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page