Fecal Immunochemical Test in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms
NCT ID: NCT06776120
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1575 participants
INTERVENTIONAL
2025-01-15
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
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).
40 Years
75 Years
ALL
Yes
Sponsors
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Department of Science and Technology, Ho Chi Minh City, Viet Nam
UNKNOWN
Luu Ngoc Mai
OTHER
Responsible Party
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Luu Ngoc Mai
University of Medicine and Pharmacy at Ho Chi Minh City
Locations
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University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Mai N Luu, MD., MSc.
Role: backup
Duc Quach, MD., PhD.
Role: backup
Other Identifiers
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3412/DHYD-HDDD
Identifier Type: -
Identifier Source: org_study_id
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