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Completed

NCT Number: NCT02037646

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

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).

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Qualitative fecal immunochemical test

Other

This test measures the amount of blood within the submitted stool specimen

Quantitative fecal immunochemical test

Other

This test detects presence or absence of blood within a submitted stool specimen.

colonoscopy

Procedure

Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.

Cost analysis

Other

Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.

Anxiety scores

Other

Hospital Anxiety and Depression Scale (HADS) questionnaire

Patient satisfaction scores

Other

A 5-point patient satisfaction score will be documented at each patient visit related to screening.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2014
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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