Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06582914

Conditions

Lynch Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The vision of the "Lynch syndrome INtegrative Epidemiology And GEnetics" (LINEAGE) Consortium is to collaboratively improve the lives and longevity of individuals and families with Lynch syndrome.

The mission of the LINEAGE Consortium is to collaboratively improve Lynch syndrome care through high-quality research. This consortium will provide intellectual and infrastructure support to facilitate development of research questions, collection of standardized data and biospecimens, support of grant applications, and generation of collaborative manuscripts.

Our aims are to:

I. Establish a prospective cohort of individuals with Lynch syndrome II. Collect standardized longitudinal clinical and biosample data to elucidate Lynch Syndrome epidemiology and gene-host interactions III. Promote intervention trials to improve cancer prevention and early detection in Lynch Syndrome

Conditions

Lynch Syndrome

Study ID

NCT06582914

Start date

Oct 1, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2054

Anticipated

Primary completion date

Dec 31, 2054

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pateints with a germline variant in a mismatch repair gene

Individuals with germline genetic testing results showing a pathogenic, likely pathogenic or variant of uncertain significance in MLH1, MSH2, MSH6, PMS2 or EPCAM.

Primary outcome measure

  • Colorectal cancer incidence [ Time Frame: 40 years ]

Central Contacts and Locations

Central contacts

Swati G Patel, MD, MS

3032170731swati.patel@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sandra Boimbo, MPH

303-724-8892Sandra.Boimbo@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 15, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-01-15.