# NIH grant: Cancer screening with cell-free DNA in Li-Fraumeni Syndrome: Feasibility study prior to national trial (1U34CA308743-01) — retained record

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NIH grant 1U34CA308743-01: Cancer screening with cell-free DNA in Li-Fraumeni Syndrome: Feasibility study prior to national trial
Institute: {'code': 'CA', 'abbreviation': 'NCI', 'name': 'National Cancer Institute', 'admin_org_id': '12500008', 'admin_funding_url': ''}. PI: Brian  Crompton. Award: $427064.
Start: 2026-07-16T00:00:00.
Project Summary
Individuals with Li-Fraumeni Syndrome (LFS) are at high risk of developing cancer, with 80-90% lifelong
chance of malignancy. Screening protocols – leaning heavily on imaging surveillance – have been shown to
improve survival through early cancer detection. However, these protocols are imperfect, with high false
positive rates and the inability to detect all cancers prior to onset of symptoms. Additionally, screening is
associated with significant anxiety and distress in people with LFS and their families. Improved methods of
cancer screening are crucial for this at-risk population, as earlier cancer detection is tied to improved survival,
improved treatment-related morbidity, and decreased secondary malignancy risk if radiation therapy can be
avoided. Early cancer detection through testing of circulating tumor DNA (ctDNA) holds great promise
for individuals with LFS. The EDISYN (Early Detection in SYNdromic Cancers) Consortium is planning a
randomized controlled trial (RCT) evaluating the efficacy of adding ctDNA screening to standard of care
screening protocols in detecting cancer earlier in individuals with LFS. This trial is being planned in
collaboration with the ECOG-ACRIN Cancer Research Group, the CHARM (cell-free DNA in Hereditary and
High-Risk Malignancies) Consortium, and patient advocacy organizations. We plan to recruit over 1,000
pediatric and adult participants with LFS at many centers across the United States, and thus pilot and
feasibility data are required prior to study initiation.
In this U34 proposal, the EDISYN Consortium will generate pilot and feasibility data that will ensure
success of the planned RCT assessing the addition of ctDNA testing to cancer screening in LFS. In
Aim 1, we will pilot ctDNA cancer screening using a test developed and validated by the CHARM Consortium,
with the hypothesis that we will provide clinically actionable results within 4 weeks to all participants, and that
subjects with a positive result will then undergo follow up testing to evaluate for malignancy with limited cost
and barriers to care. In Aim 2, we will pilot a battery of patient-reported outcome measures (PROM) to obtain
baseline data and assess acceptability of these measures for the future trial. Our hypothesis is that PROM
will describe a range of logistical and psychological barriers that will be actionable in planning the future RCT.
We expect that the completion of the above aims will inform the design of an impactful RCT hypothesizing
that ctDNA screening will improve time to cancer detection in individuals with LFS. Furthermore, these pilot
data are crucial to achieving the primary outcome of the planned RCT or - should pilot data reveal lack of
feasibility of the planned RCT - modifying the primary outcome prior to trial initiation.
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