Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral
NCT ID: NCT02037646
Last Updated: 2017-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
700 participants
INTERVENTIONAL
2012-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Qualitative fecal immunochemical test
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.
Qualitative fecal immunochemical test
This test measures the amount of blood within the submitted stool specimen
Colonoscopy
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Cost analysis
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
Patient satisfaction scores
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
Quantitative fecal immunochemical test
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.
Quantitative fecal immunochemical test
This test detects presence or absence of blood within a submitted stool specimen.
Colonoscopy
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Cost analysis
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
Patient satisfaction scores
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
Interventions
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Qualitative fecal immunochemical test
This test measures the amount of blood within the submitted stool specimen
Quantitative fecal immunochemical test
This test detects presence or absence of blood within a submitted stool specimen.
Colonoscopy
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Cost analysis
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
Patient satisfaction scores
A 5-point patient satisfaction score will be documented at each patient visit related to screening.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Personal history of colorectal tumour or cancer
* Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
50 Years
ALL
Yes
Sponsors
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University of Malaya
OTHER
Responsible Party
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Principal Investigators
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April C Roslani, MBBCh
Role: PRINCIPAL_INVESTIGATOR
University of Malaya Medical Centre
Locations
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University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Countries
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Other Identifiers
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926.24
Identifier Type: -
Identifier Source: org_study_id