Colorectal Cancer (CRC)NCT06776120
Fecal Immunochemical Test in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms
A study testing Fecal chemical test (FIT) in people with Colorectal Cancer (CRC), run by Luu Ngoc Mai at 1 site in Vietnam.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC)
- What is being tested?
- Fecal chemical test (FIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,575 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 700000
Mai N Luu, MD., MSc., 84985108132, ngmai3288@ump.edu.vn
Duc Quach, MD., PhD., 84918080225, drquachtd@gmail.com
About this study
Official title: 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:
Read more
- 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?
- Does combining FIT results with the Asia-Pacific Colorectal Screening (APCS) score improve the diagnostic accuracy for CRC in symptomatic Vietnamese individuals?
- What is the optimal quantitative FIT threshold for diagnosing CRC and excluding organic colorectal diseases (advanced colorectal polyps, inflammatory bowel disease, ischemic colitis, ...)?
- How can a standardized protocol for FIT implementation in Vietnamese symptomatic individuals be developed?
- What are the knowledge and attitudes related to CRC screening among Vietnamese patients with lower gastrointestinal symptoms?
- 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.
- Conditions
- Colorectal Cancer (CRC)
- Being tested
- Fecal chemical test (FIT)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fecal chemical test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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
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
Measured: through study completion, an average of 24 months
Optimal FIT threshold for diagnosing CRC in Vietnamese patients with lower GI symptoms
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
Measured: through study completion, an average of 24 months
Knowledge, attitude related to CRC screening of Vietnamese patients with lower GI symptoms
Measured by a questionnaire, and the measuring unit is multiple choice questions.
Measured: through study completion, an average of 24 months
The acceptability of FIT in Vietnamese patients with lower GI symptoms
Measure the level of acceptability of FIT among the study participants using a structured questionnaire.
Measured: through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,575 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luu Ngoc Mai
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Science and Technology, Ho Chi Minh City, Viet Nam
- Responsible party
- Sponsor-investigator, Luu Ngoc Mai, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776120
- Sponsor's protocol ID
- 3412/DHYD-HDDD
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Fecal Immunochemical Test (FIT) in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT06776120
- Acronym / sponsor ID
- 3412/DHYD-HDDD
- Conditions
- Colorectal Cancer (CRC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,575 participants (estimated)
- Lead sponsor
- Luu Ngoc MaiUniversity, hospital or other
- Collaborators
- Department of Science and Technology, Ho Chi Minh City, Viet Nam
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Does combining FIT results with the Asia-Pacific Colorectal Screening (APCS) score improve the diagnostic accuracy for CRC in symptomatic Vietnamese individuals?
- What is the optimal quantitative FIT threshold for diagnosing CRC and excluding organic colorectal diseases (advanced colorectal polyps, inflammatory bowel disease, ischemic colitis, ...)?
- How can a standardized protocol for FIT implementation in Vietnamese symptomatic individuals be developed?
- What are the knowledge and attitudes related to CRC screening among Vietnamese patients with lower gastrointestinal symptoms?
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vietnamese individuals with lower gastrointestinal symptoms | Other | Diagnostic Test: Fecal chemical test (FIT)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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Vietnamese individuals with lower gastrointestinal symptoms |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal chemical test (FIT) in people with Colorectal Cancer (CRC), run by Luu Ngoc Mai at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luu N Mai, MD, MSc (84985108132, ngmai3288@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.