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Clinical Trials/NCT02037646
NCT02037646
Completed
Not Applicable

Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol

University of Malaya1 site in 1 country700 target enrollmentJune 2012
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ConditionsColorectal Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
University of Malaya
Enrollment
700
Locations
1
Primary Endpoint
Time to diagnosis of advanced colorectal neoplasms
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Time to diagnosis of advanced colorectal neoplasms

Time Frame: 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 Outcomes

  • Analysis of screening costs(Up to 90 days following enrolment)
  • Patient anxiety levels(Up to 90 days after enrolment)

Study Sites (1)

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