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NCT06863038Not yet recruiting

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 · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
572 (estimated)
First submitted
28 Feb 2025
Start date
Mar 2025
Primary completion date
Mar 2027
Lead sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
NCT number
NCT06863038

What you commit to

  • Study type: Observational
  • Planned participants: 572
  • From Mar 2025 to the primary completion date, Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently using anticoagulants or antiplatelet agents

Other illness

  • Active gastrointestinal bleeding
  • History of coagulation disorders or difficulty controlling bleeding

Other

  • Incomplete colonoscopy to the cecum (excluding cases of tumor-induced obstruction)

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Medicine and Pharmacy at Ho Chi Minh City
Coordinator of this site? Confirm its status
Ho Chi Minh CityVietnamUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.