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Cancer screening with cell-free DNA in Li-Fraumeni Syndrome: Feasibility study prior to national trial

Award Number: U34CA308743
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: HEALTH SERVICES
PERIOD OF PERFORMANCE START DATE: 07/16/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2029

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Cancer screening with cell-free DNA in Li-Fraumeni Syndrome: Feasibility study prior to national trial - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $427,064 )
2026	2026	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Cancer Detection and Diagnosis Research	000	1	7/16/2026	NEW	$427,064
														Subtotal = $427,064

Grand Total All Awards = $427,064

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Cancer screening with cell-free DNA in Li-Fraumeni Syndrome: Feasibility study prior to national trial

Award Number: U34CA308743

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: HEALTH SERVICES

PERIOD OF PERFORMANCE START DATE: 07/16/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2029

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