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Lynch Syndrome Integrative Epidemiology and Genetics
NCT06582914 · University of Colorado, Denver
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Lynch Syndrome Integrative Epidemiology and Genetics (LINEAGE)
About this study
The main objective of this consortium is to build a shared resource to drive research in critical areas necessary to understand LS-related neoplasia risk and improve early detection and prevention of LS-associated cancers. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized clinical data and biospecimens, support grant applications, and generate collaborative manuscripts.
Data and samples collected for LINEAGE will allow the consortium to address a variety of topic areas including but not limited to:
I. Risk of prevalent and incident colorectal neoplasia among PV/LPV carriers. II. Estimate risk of prevalent and incident extra-colonic neoplasm among PV/LPV carriers.
III. Characterization of post-colonoscopy colorectal cancer among PV/LPV carriers.
IV. Risk factors for prevalent and incident neoplasia.
The LINEAGE Consortium is an observational prospective cohort study, with baseline and annual electronic health record (EHR) abstraction, and electronic participant and provider surveys. The consortium may also collect single or serial biosamples from identified and enrolled LS patients at participating centers.
Eligibility criteria
Inclusion Criteria:
* • Adults age over 18 years
* Eligible patients must have at least one variant of uncertain significance (VUS), pathogenic or likely pathogenic variant (PV/LPV) in MLH1, MSH2, MSH6, PMS2, or EPCAM, which will be confirmed by genetic testing results (obtained as part of routine care) and a review of the variant in ClinVar (https://www.ncbi.nlm.nih.gov/clinvar/).
* Individuals who are an obligate carrier of a LS PV/LPV that is confirmed in the family.
Exclusion Criteria:
* Age under 18
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-10-01
Estimated completion: 2054-12-31
Last updated: 2025-01-15
Primary outcomes
- • Colorectal cancer incidence (40 years)
Sponsor
University of Colorado, Denver · other
With: University of Chicago, University of Kansas, University of Pennsylvania, Johns Hopkins University, City of Hope National Medical Center, Loma Linda University, MedStar Health, University of Arizona, University of Manitoba, University of Michigan, University of North Carolina, University of Pittsburgh, University of Rochester, Dana-Farber Cancer Institute, University of Wisconsin, Madison, The Cleveland Clinic, University of California, San Diego, Kaiser Permanente, Ohio State University, Virginia Mason Hospital/Medical Center, University of Alabama at Birmingham, University of Miami
Contacts & investigators
ContactSwati G Patel, MD, MS · contact · swati.patel@cuanschutz.edu · 3032170731
ContactSonia Kupfer, MD · contact
All locations (2)
University of ColoradoRecruiting
Aurora, Colorado, United States
University of ChicagoNot Yet Recruiting
Chicago, Illinois, United States