Immune System Interaction for Lynch Syndrome
(LYNX-EYE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to prevent cancer in individuals with Lynch syndrome, a condition that significantly increases the risk of colorectal and endometrial cancer. Researchers study how the immune system interacts with the gut in those with this genetic condition. Participants will be grouped based on Lynch syndrome status, gene type, and the presence of cancer or adenomas (pre-cancerous growths). Individuals with Lynch syndrome undergoing regular cancer checks, or those without the syndrome but with colorectal issues, may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to groundbreaking cancer prevention strategies.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Lynch syndrome can increase the risk of developing colorectal and endometrial cancers, and this risk persists even with regular cancer screenings. The new treatment, LYNX EYE, is being tested to determine if it can help reduce this risk.
Detailed safety information about LYNX EYE is not yet available because this is an early-stage study. Early-stage trials typically focus on assessing the safety and tolerability of a treatment. If LYNX EYE progresses to later stages, it indicates a reasonable level of safety in these initial studies.
Participants in this trial will likely be closely monitored for any side effects. Those considering participation should discuss any concerns with the study team.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it offers a fresh perspective on how the immune system interacts with the gut lining in patients with Lynch syndrome. Unlike current approaches that focus primarily on managing cancer risk, this study aims to uncover the underlying immune responses linked to different genetic mutations and their correlation with cancer development. By exploring these interactions, researchers hope to pave the way for new prevention strategies and personalized treatments that go beyond the standard screenings and surgical interventions typically used today.
What evidence suggests that this trial's treatments could be effective for Lynch syndrome?
This trial will evaluate the effectiveness of genetic testing in identifying Lynch syndrome and its impact on colorectal cancer risk. Studies have shown that genetic testing for Lynch syndrome can significantly reduce colorectal cancer risk. Research indicates that using specific genetic information, such as testing family members, can lower the chance of developing this cancer. Early detection of Lynch syndrome and preventive measures can lead to better cancer outcomes. This method is more cost-effective than traditional approaches and can identify those at risk before cancer develops. Participants in this trial will be grouped based on their genetic status and cancer presence, allowing for a comprehensive assessment of these strategies.678910
Who Is on the Research Team?
Giulia Martina Cavestro, MD, PhD
Principal Investigator
IRCCS San Raffaele Scientific Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessment of participants including colonoscopy evaluation and collection of blood samples for biomarker analysis
Observation
Participants are monitored for the development of colorectal cancer and the presence of anti-frame-shift peptide antibodies
Follow-up
Participants are monitored for safety and effectiveness after the main observation period
What Are the Treatments Tested in This Trial?
Interventions
- LYNX EYE
How Is the Trial Designed?
14
Treatment groups
Experimental Treatment
A cohort of individuals without a germline pathogenic variant in any of the mismatch repair genes (MLH1, MSH2, MSH6, PMS2), who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals without a germline pathogenic variant in any of the mismatch repair genes (MLH1, MSH2, MSH6, PMS2), who are found to have low-risk adenomas at the time of colonoscopy evaluation
A cohort of individuals without a germline pathogenic variant in any of the mismatch repair genes (MLH1, MSH2, MSH6, PMS2), who are found to have high-risk adenomas at the time of colonoscopy evaluation
A cohort of individuals without a germline pathogenic variant in any of the mismatch repair genes (MLH1, MSH2, MSH6, PMS2), who are found to have colorectal cancer at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the PMS2 gene, that confers a diagnosis of Lynch syndrome, who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the PMS2 gene, that confers a diagnosis of Lynch syndrome, who are found to have colorectal cancer or an adenoma at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MSH6 gene, that confers a diagnosis of Lynch syndrome, who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MSH6 gene, that confers a diagnosis of Lynch syndrome, who are found to have colorectal cancer or an adenoma at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic exon 8 deletion in the MSH2 gene, that confers a diagnosis of Lynch syndrome, who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic exon 8 deletion in the MSH2 gene, that confers a diagnosis of Lynch syndrome, who are found to have colorectal cancer or an adenoma at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MSH2 gene, that confers a diagnosis of Lynch syndrome, who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MSH2 gene, that confers a diagnosis of Lynch syndrome, who are found to have colorectal cancer or an adenoma at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MLH1 gene, that confers a diagnosis of Lynch syndrome, who are found to be cancer-free and adenoma-free at the time of colonoscopy evaluation
A cohort of individuals with a germline pathogenic variant in the MLH1 gene, that confers a diagnosis of Lynch syndrome, who are found to have colorectal cancer or an adenoma at the time of colonoscopy evaluation
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Raffaele University
Lead Sponsor
Citations
Cost-effectiveness of Lynch syndrome screening in ...
The results indicate that either one of sequential testing with CLEAR-LS intervention or universal germline testing are the cost-effective ...
2.
medicine.yale.edu
medicine.yale.edu/news-article/improving-cancer-outcomes-with-better-lynch-syndrome-testing-a-cost-benefit-study/Improving Cancer Outcomes with Better Lynch Syndrome ...
This study determined that current standard-of-care was not cost effective, but both the YNHH model and universal upfront genetic testing were.
Cost-Effectiveness of Lynch Syndrome Identification ...
Using genotype-specific prevalence and penetrance data, we estimate that cascade testing can reduce the absolute risk of CRC by an overall ...
Rates and outcomes of testing for lynch syndrome in a ...
Over five years, 206 CRCs were diagnosed. Testing for LS was carried out for 100% of CRCs at site A and 69% of CRCs at site B. Of CRCs tested for LS, 14 (8%) ...
Cost-effectiveness of Active Identification and Subsequent ...
Results: Testing 1000 CRC cases was estimated to identify 20 CRC index cases and 29 FDRs with Lynch syndrome at a cost of $310,274. Despite the high cost ...
Lynch Syndrome - GeneReviews® - NCBI Bookshelf - NIH
The Prospective Lynch Syndrome Database estimates the risk of prostate cancer for men with an MSH2 pathogenic variant at 16%, and 5%-7% for men ...
Lynch syndrome - Symptoms and causes
Lynch syndrome is a condition that increases the risk of many kinds of cancer. This condition is passed from parents to children.
Lynch Syndrome
Individuals at risk for Lynch syndrome usually have a family history of two successive generations of colon or rectal cancer. Or they have at least one ...
LYNX-EYE: Lynch Syndrome X-Talk of Enteral Mucosa ...
Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals.
Lynch syndrome: MedlinePlus Genetics
Lynch syndrome, often called hereditary nonpolyposis colorectal cancer (HNPCC), is an inherited disorder that increases the risk of many types of cancer.
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