Clinical trial · Observational
Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Vietnam
Predictive Value of the PREMM5, MMRpredict Models, and the Universal Tumor Screening Strategy for Lynch Syndrome in Vietnam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the predictive value of PREMM5, MMRpredict models, and Universal Tumor Screening in detecting Lynch Syndrome in colorectal cancer (CRC) patients in Vietnam. Vietnamese CRC patients (18-70 years) undergoing colonoscopy will be enrolled. Participants will complete a medical history questionnaire and provide blood samples for genetic testing. Tumor biopsy specimens will undergo Immunohistochemistry staining, BRAF V600E mutation, and MLH1 methylation analysis in case of loss of MLH1/PMS2 expression. Next-Generation Sequencing will detect germline MMR mutations, and biallelic somatic mutations will be analyzed if no germline mutations are found.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Predictive Value of PREMM5, MMRpredict, and Universal Tumor Screening for Lynch Syndrome in Colorectal Cancer Patients
- timeFrame
- At study completion (Month 24). The primary outcome will be analyzed after all participants have completed sample collection, genetic testing, and data processing, expected within 24 months from study initiation.
- description
- The study evaluates the diagnostic accuracy of PREMM5, MMRpredict models, and Universal Tumor Screening (IHC testing) in detecting Lynch Syndrome (LS) in colorectal cancer (CRC) patients. The outcome will be assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC-ROC) for each screening method compared to gold-standard germline MMR gene mutation testing (via Next-Generation Sequencing - NGS).
Secondary outcomes (4)
- measure
- Prevalence of Lynch Syndrome in Colorectal Cancer Patients
- timeFrame
- At study completion (Month 24)
- description
- This outcome measures the proportion of colorectal cancer (CRC) patients diagnosed with Lynch Syndrome (LS) based on germline MMR gene mutation testing (via Next-Generation Sequencing - NGS). The prevalence will be reported as a percentage of the total study population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 to 70 years * Provide informed consent to participate in the study * Undergo colonoscopy with endoscopic findings suspicious for CRC * Have biopsy-confirmed adenocarcinoma through colonoscopic biopsy Exclusion Criteria: * Active gastrointestinal bleeding * Currently using anticoagulants or antiplatelet agents * History of coagulation disorders or difficulty controlling bleeding * Incomplete colonoscopy to the cecum (excluding cases of tumor-induced obstruction)
References
Publications (0)
Data not yet available