NCT06990633Not yet recruiting
Lynch Syndrome in Colorectal Cancer Surgery
LYNX STUDY: Lynch Syndrome in Colorectal Cancer Surgery - A Multicentre, Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Study Design (Material and Methods) This is a multicentre, prospective cohort and audit study conducted in Türkiye. The study aims to evaluate the incidence of Lynch syndrome among patients who undergo surgery for colorectal cancer in participating general surgery departments. Over a 12-month period, patients undergoing surgery for histologically confirmed colorectal cancer at multiple tertiary hospitals across Türkiye will be enrolled. Postoperative pathological assessments will include immunohistochemical (IHC) analysis for mismatch repair (MMR) protein expression (MLH1, PMS2, MSH2, and MSH6). In cases showing loss of MLH1 and PMS2 expression, BRAF mutation testing will be performed. If BRAF mutation is detected, MLH1 promoter methylation analysis will follow. A positive result in both tests will suggest a sporadic etiology, whereas the absence of both findings will lead to referral for germline genetic testing using next-generation sequencing (NGS) to investigate Lynch syndrome. For patients with isolated MSH2 and/or MSH6 loss, direct referral to genetic testing will be carried out without BRAF or methylation testing. Patients with intact MMR expression will be recorded as the MMR-proficient control group. Comparative analysis will be conducted between dMMR and MMR-proficient patients, including demographic characteristics (age, sex, family history of cancer), tumor staging, anatomical location, and presence of metastases. The primary outcome is to determine the incidence of Lynch syndrome among surgically treated colorectal cancer patients in Türkiye and to identify clinical and pathological correlations.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 17 May 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06990633
What you commit to
- Study type: Observational
- Planned participants: 180
- From 1 Jul 2025 to the primary completion date, 1 Jul 2026
- No sites listed in no 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.
Age
- Age below 18 years
Other
- Diagnosis other than colorectal adenocarcinoma
- Incomplete or unavailable postoperative pathology results
- Inadequate tissue samples for IHC analysis
- Patients who decline participation in the study at any point
- Patients who do not attend or refuse referral to genetic counseling after pathology results
Who the study is looking for
- Age 18 years or older
- Histologically confirmed diagnosis of colorectal adenocarcinoma
- Undergoing surgical resection at one of the participating general surgery departments
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue for MMR analysis
- Consent to participate in the study and undergo genetic testing if indicated
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.