Improving care for individuals with Lynch syndrome
Lynch Syndrome Integrative Epidemiology and Genetics (LINEAGE)
This study is trying to improve care for people with Lynch syndrome by collecting health information and samples to better understand the condition and support new ways to prevent and detect cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06582914 on ClinicalTrials.gov |
What this trial studies
The LINEAGE Consortium aims to enhance the lives of individuals and families affected by Lynch syndrome through collaborative research. This observational study will establish a prospective cohort of patients with Lynch syndrome, collecting standardized clinical data and biosamples to investigate the epidemiology and genetic factors associated with the condition. The consortium will also support intervention trials focused on cancer prevention and early detection strategies for those at risk. By leveraging electronic health records and participant surveys, the study seeks to generate valuable insights into Lynch syndrome-related cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed pathogenic or likely pathogenic variant in specific Lynch syndrome-related genes.
Not a fit: Patients under 18 years old or those without a confirmed genetic variant associated with Lynch syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cancer prevention and early detection strategies for patients with Lynch syndrome.
How similar studies have performed: Other studies focusing on Lynch syndrome have shown promise in understanding cancer risks and improving patient outcomes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Swati G Patel, MD, MS
- Email: swati.patel@cuanschutz.edu
- Phone: 3032170731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.