About this trial
This research study aims to learn more about changes in the TP53 gene. These changes can be linked to Li-Fraumeni Syndrome, a hereditary condition that increases cancer risk. The study wants to understand cancer risks better for those with TP53 variants. It will help improve cancer prevention and treatment opportunities. Participants will provide medical information and may give blood, saliva, or other samples.
The trial's ID is NCT04541654. This is not a drug study, and it does not involve FDA-regulated devices. The study plans to include about 1500 participants.
Who can join
This study is open to all ages, including children and older adults. Individuals with a known TP53 variant, their relatives, or those who meet specific criteria for Li-Fraumeni Syndrome can join. People must agree to participate and be able to give consent. Those who cannot consent or decline are not eligible. The study team will confirm who can join.
Conditions
Li-Fraumeni Syndrome, TP53 Gene Mutation, Hereditary Cancer Syndrome, Clonal Hematopoiesis, Mosaicism
The study team makes the final call on eligibility.
What happens in the study
Participants will provide information from their medical records and answer questionnaires. They may also give blood or saliva samples and optional tissue samples. Everyone will be part of a group based on having a TP53 variant or being related to someone who does. This is an observational study, so there are no specific treatments given.
Where
This trial is running at 3 locations in the United States. All of them are currently recruiting.
Boston Children's Hospital
Boston, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts
Judy E. Garber
Boston, Massachusetts