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

NCT06776120 | Not Yet Recruiting

• 1 other identifier: 3412/DHYD-HDDD
• Study Type: interventional
• Target: 1,575
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Colorectal Cancer (CRC)

Outcome Measures

Primary Outcomes (1)

• The diagnostic performances of FIT using one and two stool samples in detecting CRC among Vietnamese patients with lower GI symptoms

  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 Outcomes (5)

• 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

  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

  through study completion, an average of 24 months

• Optimal FIT threshold for diagnosing 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

  through study completion, an average of 24 months

• The acceptability of FIT in Vietnamese patients with lower GI symptoms

  through study completion, an average of 24 months

Study Arms (1)

Vietnamese individuals with lower gastrointestinal symptoms

OTHER

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)

Interventions

Fecal chemical test (FIT) DIAGNOSTIC_TEST

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.

Vietnamese individuals with lower gastrointestinal symptoms

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of chronic inflammatory bowel disease, diverticular disease of the colon, colorectal surgery, polypectomy, colorectal cancer, artificial heart valves, or vascular graft surgery.
• Previous colorectal diagnostic imaging, including colonoscopy, sigmoidoscopy, computed tomography (CT) colonography, or barium enema.
• 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).
• Symptoms or signs of anorectal tumors or anal ulcers.
• Acute diarrhea lasting ≤14 days.
• Current use of aspirin, antiplatelet agents, anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs), as these may cause false-positive FIT results.
• Diagnosis of hereditary colorectal cancer syndromes (e.g., Lynch syndrome or familial adenomatous polyposis).
• Pregnancy, breastfeeding, or menstruation at the time of the study.
• Contraindications to colonoscopy.
• 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).

Sponsors & Collaborators

• Luu Ngoc Mai: lead
• Department of Science and Technology, Ho Chi Minh City, Viet Nam: collaborator

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Luu N Mai, MD, MSc

CONTACT

84985108132; ngmai3288@ump.edu.vn

Duc Quach, MD, PhD

CONTACT

84918080225; drquachtd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University of Medicine and Pharmacy at Ho Chi Minh City

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)