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NCT04541654 · ClinicalTrials.gov registry record
Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress
A clinical trial of Li-Fraumeni Syndrome and Hereditary Cancer Syndrome, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 3
- Study locations
NCT04541654: Recruiting study of Li-Fraumeni Syndrome and Hereditary Cancer Syndrome, sponsored by Dana-Farber Cancer Institute.
NCT04541654 is a study of Li-Fraumeni Syndrome and Hereditary Cancer Syndrome that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 1,500 participants, below the 1,826-participant average among 6 other Li-Fraumeni Syndrome trials with a reported enrollment target (18% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04541654, a study of Li-Fraumeni Syndrome and Hereditary Cancer Syndrome, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 3
- Study locations
Study 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).
Primary Outcome
Examine accuracy of family history and the extent to which families meet various published Li-Fraumeni family criteria or assess for de-novo mutations using descriptive statistics. Exact binomial confidence limits for percents will be calculated at 95% coverage. Tests of difference between \>2 groups for binary variables will use the Fisher exact test.
Conditions Studied
Interventions
- GENETIC Data and Specimen Collection
Study Locations (3)
Massachusetts
- Boston Children's Hospital - Boston
- Brigham and Women's Hospital - Boston
- Judy E. Garber - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2025-12-31 |
What NCT04541654 shows while recruiting
NCT04541654 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 1,826-participant average among 6 other Li-Fraumeni Syndrome trials with a reported enrollment target (18% lower).
The record links to 5 conditions, with Li-Fraumeni Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Data and Specimen Collection is the first listed.
NCT04541654 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04541654 about?
NCT04541654 is a clinical study titled "Li-Fraumeni & TP53 (LiFT UP): Understanding and Progress". 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).
What is the current status of trial NCT04541654?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2020-09-15. Estimated completion is 2025-12-31.
What conditions does trial NCT04541654 study?
This clinical trial studies the following conditions: Li-Fraumeni Syndrome, Hereditary Cancer Syndrome, Clonal Hematopoiesis, Mosaicism, TP53 Gene Mutation.
What interventions are being tested in trial NCT04541654?
The interventions under investigation include: Data and Specimen Collection (GENETIC).
Who is sponsoring clinical trial NCT04541654?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04541654 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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