Fecal Immunochemical Test in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms

January 13, 2025 updated by: Luu Ngoc Mai

The Performance of Fecal Immunochemical Test (FIT) in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms

The goal of this clinical trial is to evaluate the diagnostic value of fecal immunochemical tests (FIT) in identifying colorectal cancer (CRC) among Vietnamese individuals presenting with lower gastrointestinal symptoms.

The main questions it aims to answer are:

  1. Does a quantitative FIT with a positive threshold of 10 µg/g effectively diagnose CRC in symptomatic Vietnamese individuals using one and two stool samples?
  2. Does combining FIT results with the Asia-Pacific Colorectal Screening (APCS) score improve the diagnostic accuracy for CRC in symptomatic Vietnamese individuals?
  3. What is the optimal quantitative FIT threshold for diagnosing CRC and excluding organic colorectal diseases (advanced colorectal polyps, inflammatory bowel disease, ischemic colitis, ...)?
  4. How can a standardized protocol for FIT implementation in Vietnamese symptomatic individuals be developed?
  5. What are the knowledge and attitudes related to CRC screening among Vietnamese patients with lower gastrointestinal symptoms?
  6. What is the acceptability of FIT as a diagnostic tool among Vietnamese patients with lower gastrointestinal symptoms?

Researchers will evaluate the diagnostic performance of FIT with and without the APCS score to determine the optimal approach for identifying patients requiring colonoscopy.

Participants will:

  • Provide two stool samples for quantitative FIT.
  • Complete a questionnaire assessing clinical and demographic factors, as well as their knowledge, attitudes toward CRC screening, and acceptability of FIT.
  • Undergo diagnostic colonoscopy to confirm the presence or absence of colorectal diseases.

This study aims to enhance CRC diagnostic strategies and establish FIT as a widely acceptable and non-invasive diagnostic tool in resource-limited settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1575

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:
        • Contact:
        • Contact:
          • Mai N Luu, MD., MSc.
        • Contact:
          • Duc Quach, MD., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Aged 40 - 75 years.
  • Informed consent available.
  • Patients with lower GI symptoms (patients who experience at least one month of any lower GI symptoms: lower abdominal pain, constipation, diarrhea, changes in stool caliber, and abdominal bloating) who are scheduled for a first-time screening colonoscopy.

Exclusion Criteria: Individuals meeting any of the following exclusion criteria will be excluded from the study:

  1. History of chronic inflammatory bowel disease, diverticular disease of the colon, colorectal surgery, polypectomy, colorectal cancer, artificial heart valves, or vascular graft surgery.
  2. Previous colorectal diagnostic imaging, including colonoscopy, sigmoidoscopy, computed tomography (CT) colonography, or barium enema.
  3. Presence of alarm symptoms, including lower gastrointestinal bleeding (hematochezia or melena), an abdominal mass, or unexplained clinically significant weight loss (loss of more than 5 kg or 5-10% of body weight over the past 6 months).
  4. Symptoms or signs of anorectal tumors or anal ulcers.
  5. Acute diarrhea lasting ≤14 days.
  6. Current use of aspirin, antiplatelet agents, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs), as these may cause false-positive FIT results.
  7. Diagnosis of hereditary colorectal cancer syndromes (e.g., Lynch syndrome or familial adenomatous polyposis).
  8. Pregnancy, breastfeeding, or menstruation at the time of the study.
  9. Contraindications to colonoscopy.
  10. Incomplete colonoscopy due to failure to advance the scope to the cecum or inadequate bowel preparation (Boston Bowel Preparation Scale [BBPS] score <6 or a segment score <2).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Vietnamese individuals with lower gastrointestinal symptoms

Vietnamese patients aged 40 - 75 years with lower GI symptoms (patients who have experienced at least one month of any lower GI symptoms: lower abdominal pain, constipation, diarrhea, changes in stool caliber, and abdominal bloating) who are examined at the Outpatient Department of the University Medical Center in Ho Chi Minh City or at the Outpatient Department of Nhan Dan Gia Dinh Hospital, Ho Chi Minh City, Vietnam, and are indicated to undergo a first-time screening colonoscopy, will be invited to participate in the study.

Eligible participants will be instructed to collect their two stool samples within seven days before undergoing bowel preparation. These stool samples will be then submitted for a quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan). Colonoscopic observations and histopathological findings will be employed as the definitive reference standards for diagnosis.
Diagnostic test: Fecal chemical test (FIT)
Eligible participants will be instructed to collect their two stool samples within seven days prior to undergoing bowel preparation. These stool samples will be then submitted for a quantitative FIT (OC-SENSOR, EIKEN CHEMICAL, Japan). Colonoscopic observations and histopathological findings will be employed as the definitive reference standards for diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic performances of FIT using one and two stool samples in detecting CRC among Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FIT (with a positive threshold of 10 µg/g) using one and two stool samples to detect colorectal cancer (CRC), as confirmed by colonoscopy and histopathological findings.
through study completion, an average of 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic performances of FIT using one and two stool samples combined with APCS scores in detecting CRC among Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months

The sensitivity, specificity, PPV, and NPV of FIT (with a positive threshold of 10 µg/g) using one and two stool samples, combined with the Asia-Pacific Colorectal Screening (APCS) scores, to detect CRC, as confirmed by colonoscopy and histopathological findings.

The APCS system consists of four variables (age, sex, smoking history, and family history of CRC). The APCS scores range from 0 to 7. Based on the APCS score, participants will be categorized into three groups: average risk (APCS 0 - 1), moderate risk (APCS 2 - 3), and high risk (APCS 4 - 7).
through study completion, an average of 24 months
The diagnostic performances of FIT as a 'rule-out' test for significant colorectal diseases (i.e. CRC, advanced colorectal polyps, inflammatory bowel disease, ischemic colitis …) among Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months
The sensitivity, specificity, NPV, and PPV of FIT (with a positive threshold of 10 µg/g) using one and two stool samples to rule out significant colorectal diseases (e.g., CRC, advanced colorectal polyps, inflammatory bowel disease, ischemic colitis) among Vietnamese patients presenting with lower gastrointestinal symptoms
through study completion, an average of 24 months
Optimal FIT threshold for diagnosing CRC in Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months
The quantitative FIT threshold using one and two stool samples that maximizes the sensitivity and the specificity to detect CRC in Vietnamese patients with lower GI symptoms
through study completion, an average of 24 months
Knowledge, attitude related to CRC screening of Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months
Measured by a questionnaire, and the measuring unit is multiple choice questions.
through study completion, an average of 24 months
The acceptability of FIT in Vietnamese patients with lower GI symptoms
Time Frame: through study completion, an average of 24 months
Measure the level of acceptability of FIT among the study participants using a structured questionnaire.
through study completion, an average of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luu Ngoc Mai

Collaborators

Department of Science and Technology, Ho Chi Minh City, Viet Nam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3412/DHYD-HDDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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