Colorectal Cancer (CRC)
Conditions
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: 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_TESTFecal 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.
Sponsors
Department of Science and Technology, Ho Chi Minh City, Viet Nam
Luu Ngoc Mai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The diagnostic performances of FIT using one and two stool samples in detecting CRC among Vietnamese patients with lower GI symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 | 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 |
| Optimal FIT threshold for diagnosing CRC in Vietnamese patients with lower GI symptoms | 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 |
| Knowledge, attitude related to CRC screening of Vietnamese patients with lower GI symptoms | through study completion, an average of 24 months | Measured by a questionnaire, and the measuring unit is multiple choice questions. |
| The acceptability of FIT in Vietnamese patients with lower GI symptoms | through study completion, an average of 24 months | Measure the level of acceptability of FIT among the study participants using a structured questionnaire. |
Countries
Vietnam
Contacts
Primary ContactLuu N Mai, MD, MSc
Backup ContactDuc Quach, MD, PhD
Outcome results
None listed