NCT04541654 Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress
| NCT ID | NCT04541654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Li-Fraumeni Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2020-09-15 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2020-09-15 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to learn more about variants in the TP53 gene both associated with Li-Fraumeni Syndrome (LFS), a hereditary cancer risk condition, and TP53 variants found in the blood for other reasons (e.g. ACE/CHIP and mosaicism).
Eligibility Criteria
Inclusion Criteria: * Individuals with a TP53 pathogenic or likely pathogenic variant identified in blood or saliva, * Individuals with variants of uncertain significance in TP53 may be eligible at the PI's discretion, * Blood relatives of individuals with a TP53 variant, who may be presumed obligate carriers or healthy controls, * Individuals who meet Classic or Chompret LFS criteria whether or not they have a TP53 gene variant, * Individuals may enroll their deceased relatives in the study. * Individuals with a known TP53 variant that is not LFS, but rather ACE, CHIP, or mosaicism. * Individuals participating in other LFS studies can still enroll in LiFT UP. Investigators may be collaborators. Exclusion Criteria: * Individuals who decline to sign consent * Individuals who are unable to give consent or assent and are without a designated healthcare proxy
Contact & Investigator
Judy E Garber, MD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT04541654 clinical trial?
This trial is open to participants of all sexes, studying Li-Fraumeni Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04541654 currently recruiting?
Yes, NCT04541654 is actively recruiting participants. Contact the research team at jegarber@partners.org for enrollment information.
Where is the NCT04541654 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Boston, United States.
Who is sponsoring the NCT04541654 clinical trial?
NCT04541654 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Judy E Garber, MD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 1,500 participants.