Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062667) titled 'Multicenter Collaborative Registry Study of Lynch Syndrome' on Aug. 24.

Study Type: Observational

Primary Sponsor: Institute - Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Condition: Condition - Lynch syndrome Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - This study aims to clarify the malignant tumor profile, cancer risk, treatment course, recurrence, and prognosis in Lynch syndrome, and to establish appropriate surveillance. Basic objectives2 - Others

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Individuals diagnosed with Lynch syndrome by genetic testing 1) or individuals judged to be genetically appropriate as having Lynch syndrome 2) 1) Carriers of a pathogenic variant in a mismatch repair gene that, as of the time of registration, has been judged pathogenic or likely pathogenic by any public database (excluding in silico analysis) or by the ACMG/AMP guidelines 2) Cases judged to be appropriate as having Lynch syndrome - When a second-degree relative has been diagnosed with Lynch syndrome based on the same variant, the first-degree relatives of both individuals (e.g., the father, when the individual and the paternal grandfather have been diagnosed) 2. Individuals aged 16 years or older at the time of consent 3. Individuals who have undergone surveillance for Lynch syndrome at least once at a collaborating institution 3) 3) "Surveillance" refers to examinations and tests performed to check for the presence or absence of tumor development, and does not include consultations, genetic counseling, genetic testing, etc. 4. For the "prospective observational study," individuals who, after receiving a full explanation regarding participation in this study and gaining full understanding, provided written consent of their own free will Note: Participation in this study does not depend on the timing of Lynch syndrome diagnosis, participation in other clinical studies, or the presence or absence of tumor development. Note: Individuals whose tumor tissue showed microsatellite instability or loss of mismatch repair protein expression (in the case of colorectal cancer, this also includes BRAF wild-type cases), as well as first-degree relatives of individuals with Lynch syndrome who have developed a Lynch syndrome-associated tumor, are excluded from eligibility. Key exclusion criteria - 1. Individuals whose genetic testing identified a variant classified as a Variant of Unknown Significance (VUS) 2. For the "retrospective observational study," individuals who declined to participate in the study 3. Other individuals judged by the principal investigator to be inappropriate as study subjects Target Size - 400

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 10 Day Date of IRB - 2026 Year 02 Month 10 Day Anticipated trial start date - 2026 Year 02 Month 10 Day Last follow-up date - 2036 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071739

Disclaimer: Curated by HT Syndication.