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Quantitative Versus Qualitative Fecal Immunochemical Tests (FIT) to Prioritize Urgency of Colonoscopy Referral

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ClinicalTrials.gov Identifier: NCT02037646
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Qualitative fecal immunochemical test Other: Quantitative fecal immunochemical test Procedure: Colonoscopy Other: Cost analysis Other: Anxiety scores Other: Patient satisfaction scores Not Applicable

Detailed Description:
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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 Start Date : June 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

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U.S. FDA Resources

Arm Intervention/treatment
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.

Other: Qualitative fecal immunochemical test
This test measures the amount of blood within the submitted stool specimen
Procedure: Colonoscopy
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Other: Cost analysis
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Other: Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
Other: 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.

Other: Quantitative fecal immunochemical test
This test detects presence or absence of blood within a submitted stool specimen.
Procedure: Colonoscopy
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
Other: Cost analysis
Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Other: Anxiety scores
Hospital Anxiety and Depression Scale (HADS) questionnaire
Other: Patient satisfaction scores
A 5-point patient satisfaction score will be documented at each patient visit related to screening.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Analysis of screening costs [ Time Frame: Up to 90 days following enrolment ]
    Total costs incurred as a result of the screening process

  2. Patient anxiety levels [ Time Frame: Up to 90 days after enrolment ]
    As measured by the Hospital Anxiety and Depression Scale (HADS)



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037646


Locations
Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: April C Roslani, MBBCh University of Malaya Medical Centre

Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02037646     History of Changes
Other Study ID Numbers: 926.24
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University of Malaya:
Colorectal cancer
Screening
Fecal occult blood
Fecal immunochemical test
Qualitative
Quantitative

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases