Back to resultsQuantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Qualitative fecal immunochemical test
Quantitative fecal immunochemical test
Colonoscopy
Cost analysis
Anxiety scores
Patient satisfaction scores
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative
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
Sites / Locations
- University of Malaya Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Qualitative fecal immunochemical test
Quantitative fecal immunochemical test
Arm Description
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows: >200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows: Positive - colonoscopy as per waiting list Negative - no colonoscopy Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Outcomes
Primary Outcome Measures
Time to diagnosis of advanced colorectal neoplasms
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
Secondary Outcome Measures
Analysis of screening costs
Total costs incurred as a result of the screening process
Patient anxiety levels
As measured by the Hospital Anxiety and Depression Scale (HADS)
Full Information
NCT ID
NCT02037646
First Posted
January 14, 2014
Last Updated
October 25, 2017
Sponsor
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT02037646
Brief Title
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal cancer, Screening, Fecal occult blood, Fecal immunochemical test, Qualitative, Quantitative
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Qualitative fecal immunochemical test
Arm Type
Other
Arm Description
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Arm Title
Quantitative fecal immunochemical test
Arm Type
Other
Arm Description
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention Type
Other
Intervention Name(s)
Qualitative fecal immunochemical test
Intervention Description
This test measures the amount of blood within the submitted stool specimen
Intervention Type
Other
Intervention Name(s)
Quantitative fecal immunochemical test
Intervention Description
This test detects presence or absence of blood within a submitted stool specimen.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Intervention Type
Other
Intervention Name(s)
Cost analysis
Intervention Description
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Intervention Type
Other
Intervention Name(s)
Anxiety scores
Intervention Description
Hospital Anxiety and Depression Scale (HADS) questionnaire
Intervention Type
Other
Intervention Name(s)
Patient satisfaction scores
Intervention Description
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
Primary Outcome Measure Information:
Title
Time to diagnosis of advanced colorectal neoplasms
Description
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
Time Frame
40-90 days from the time of enrolment
Secondary Outcome Measure Information:
Title
Analysis of screening costs
Description
Total costs incurred as a result of the screening process
Time Frame
Up to 90 days following enrolment
Title
Patient anxiety levels
Description
As measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame
Up to 90 days after enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
April C Roslani, MBBCh
Organizational Affiliation
University of Malaya Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
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