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Using Genetic Insights to Improve Cancer Prevention and Treatment

NCT04541654 · Recruiting
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.

Locations and contact

This trial is running at 3 locations in the United States. All of them are currently recruiting.

United States3 locations · 3 recruiting
  • Boston Children's HospitalBoston, MassachusettsRecruiting
  • Brigham and Women's HospitalBoston, MassachusettsRecruiting
  • Judy E. GarberBoston, MassachusettsRecruiting
Who to ask about joining
Judy E Garber, MD, MPH617-632-5770jegarber@partners.org
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.

What happens during the trial

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.

The trial team

The study is led by Judy E Garber, MD, MPH at Dana-Farber Cancer Institute. It is supported by the National Cancer Institute and involves City of Hope Medical Center and Baylor College of Medicine.

Important dates

The study started on September 15, 2020, and is currently recruiting new participants. It is expected to finish by December 31, 2032, with primary data collection expected to complete by December 31, 2030.

Additional information

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.

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