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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Malaya
Sponsor:
Information provided by (Responsible Party):
University of Malaya
ClinicalTrials.gov Identifier:
NCT02037646
First received: January 14, 2014
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention
Colorectal Cancer
Other: Qualitative fecal immunochemical test
Other: Quantitative fecal immunochemical test
Procedure: Colonoscopy
Other: Cost analysis
Other: Anxiety scores
Other: Patient satisfaction scores

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Time to diagnosis of advanced colorectal neoplasms [ Time Frame: 40-90 days from the time of enrolment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of screening costs [ Time Frame: Up to 90 days following enrolment ] [ Designated as safety issue: No ]
  • Patient anxiety levels [ Time Frame: Up to 90 days after enrolment ] [ Designated as safety issue: No ]
  • Patient satisfaction scores [ Time Frame: Up to 90 days after enrolment ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037646

Contacts
Contact: April C Roslani, MBBCh april@ummc.edu.my
Contact: Chirk-Jenn Ng, MBBS ngcj@ummc.edu.my

Locations
Malaysia
University of Malaya Medical Centre Recruiting
Kuala Lumpur, Malaysia, 59100
Principal Investigator: April C Roslani, MBBCh         
Sub-Investigator: Chirk-Jenn Ng, MBBS         
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: April C Roslani, MBBCh University of Malaya Medical Centre
  More Information

No publications provided

Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02037646     History of Changes
Other Study ID Numbers: 926.24
Study First Received: January 14, 2014
Last Updated: January 15, 2014
Health Authority: Malaysia: National Medical Research Register

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

ClinicalTrials.gov processed this record on July 23, 2014