Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06776120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2024-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fecal Immunochemical Test in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms
Sponsor:
Luu Ngoc Mai
Organization:
Study Overview
Official Title:
The Performance of Fecal Immunochemical Test (FIT) in Diagnosing Colorectal Cancer Among Vietnamese Patients with Lower Gastrointestinal Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: