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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]

Secondary outcome measures (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 [Time frame: 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]
• Optimal FIT threshold for diagnosing CRC in Vietnamese patients with lower GI symptoms [Time frame: 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]
• The acceptability of FIT in Vietnamese patients with lower GI symptoms [Time frame: through study completion, an average of 24 months]

Eligibility criteria

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:

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Vietnam · 1 center

• University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Identifiers

NCT: NCT06776120 · 3412/DHYD-HDDD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗