RECRUITING

Lynch Syndrome X-Talk of Enteral Mucosa With Immune System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Lynch syndrome (OMIM #120435) is the most common dominantly inherited colorectal cancer syndrome with an estimated prevalence of 1:270 individuals. It increases the lifetime risk of colorectal and endometrial cancer primarily, but it is associated with a high risk of other cancers (pancreas, stomach, ovarian, central nervous system, skin, among others). It is caused by a germline mutation in one of four DNA mismatch repair genes or a terminal deletion of the MSH2-adjacent gene EpCAM. Despite adherence to cancer surveillance programs, many patients still develop colorectal cancer and endometrial cancer. The Prospective Lynch Syndrome Database (PLSD) suggests that more frequent surveillance intervals do not significantly improve cancer risk reduction. The PLSD also revealed that the incidence of colorectal cancer in MLH1 and MSH2 carriers was even higher than previously expected, reaching as high as 41-36% among MLH1 carriers, regardless of ethnic background. The development of colorectal cancer despite surveillance is an unresolved question. Therefore, there is an unmet need for effective cancer prevention strategies.

Official Title

Impact of Immune-surveillance on the Development of Colorectal Cancer in Patients With Lynch Syndrome

Quick Facts

Study Start:2023-06-01
Study Completion:2034-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06708429

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Giulia Martina Cavestro, MD, PhD
CONTACT
0226436303
cavestro.giuliamartina@hsr.it
Alessandro Mannucci, MD
CONTACT
0226436303
mannucci.alessandro@hsr.it

Principal Investigator

Giulia Martina Cavestro, MD, PhD
PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute

Study Locations (Sites)

Beckman Research Institute at City of Hope
Monrovia, California, 91016
United States

Collaborators and Investigators

Sponsor: San Raffaele University

  • Giulia Martina Cavestro, MD, PhD, PRINCIPAL_INVESTIGATOR, IRCCS San Raffaele Scientific Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2034-06-01

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2034-06-01

Terms related to this study

Keywords Provided by Researchers

  • Colorectal cancer
  • Endometrial cancer
  • Lynch syndrome-associated cancer
  • Surveillance
  • Cancer surveillance
  • Immune profile
  • Immune escape
  • Mismatch repair deficiency
  • Microbiota
  • Liquid biopsy
  • MicroRNA
  • Transcriptomic
  • Frame shift peptides
  • MLH1
  • MSH2
  • EpCAM
  • MSH6
  • PMS2
  • Hair matrix

Additional Relevant MeSH Terms

  • Lynch Syndrome
  • Lynch Syndrome I
  • Lynch Syndrome II
  • Lynch Syndrome I (Site-specific Colonic Cancer)
  • HNPCC
  • HNPCC Gene Mutation
  • Hereditary Cancer Syndrome
  • Hereditary Cancer
  • MLH1 Gene Mutation
  • MLH1 Gene Deletion+Duplication
  • MLH1 Loss of Expression
  • MLH1 Gene Inactivation
  • MSH2 Gene Mutation
  • MSH2 Gene Deletion+Duplication
  • MSH2 Loss of Expression
  • MSH2 Gene Inactivation
  • MSH6 Gene Mutation
  • MSH6 Loss of Expression
  • MSH6 Gene Inactivation
  • PMS2 Gene Mutation
  • PMS2 Gene Inactivation
  • PMS2 Loss of Expression