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Circulating Cell-Free DNA as a Personalized Biomarker to Diagnose and Monitor Glioblastoma Extension

Award Number: R37CA246183
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2025
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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Circulating Cell-Free DNA as a Personalized Biomarker to Diagnose and Monitor Glioblastoma Extension - PROJECT SUMMARY/ABSTRACT Glioblastoma (GBM) is the most common and most aggressive adult primary brain tumor. Regardless of therapy, the median survival time is less than 15 months as GBM nearly always recurs. Diagnosing GBM currently depends on acquiring tumor tissue for histologic examination to differentiate GBM from other types of brain lesions with a similar imaging appearance. Detecting GBM recurrence is also challenging as treatment effects such as pseudoprogression and radiation necrosis mimic recurrent disease. Thus, risk-associated diagnostic invasive procedures remain a critical aspect of GBM patient care even though surgically acquired neurologic deficits may reduce an already short survival time. Therefore, a non-invasive approach to diagnose GBM and identify true recurrence has the potential to directly impact patient care throughout the entire disease course. DNA released from cells during programmed cell death, termed cell-free DNA, is an emerging biomarker for diagnosing human cancers and monitoring response to therapy. Detection of tumor-derived cell- free DNA in plasma, also known as circulating tumor DNA (ctDNA), has previously been largely unsuccessful in humans with GBM due to an inability to find the ctDNA amongst the abundant background of normally occurring cell-free DNA. The large intra- and inter-tumor genetic heterogeneity of GBM has hindered searches for specific tumor variants in cell-free DNA, while the rarity of GBM to metastasize beyond the central nervous system has considerably restricted the quantity of ctDNA present. However, our uncovering of ctDNA in a xenograft brain tumor model using human GBM stem-like cells strongly supports the feasibility of detecting GBM-derived ctDNA in humans. Moreover, our previous success in the animal model provides direction for the human translation – reducing or eliminating noise associated with next-generation sequencing (NGS) that interferes with the detection of very low frequency variants is necessary to allow searches for ctDNA that are not dependent on a priori knowledge of solid tumor variants. In this proposal, we attenuate NGS-related noise and demonstrate the unbiased detection of GBM-derived ctDNA at time of initial diagnosis and at recurrence. We also show that identification of GBM solid tumor DNA variants in ctDNA is enhanced by reducing errors associated with NGS to improve sampling of the solid tumor genetic heterogeneity typical of GBM. Therefore, this proposal seeks to translate plasma cell-free DNA as a biomarker to detect GBM in humans by suppressing errors associated with NGS to improve variant detection at very low allele frequencies. The successful application of ctDNA biomarkers to non-invasively assess GBM will directly affect patient care by enabling the optimization of clinical management prior to or instead of risk-associated invasive diagnostic procedures.


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 = $316,637 )
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	7	2/2/2026	NON-COMPETING CONTINUATION	$316,637
														Subtotal = $316,637

Issue Date FY: 2025 ( Subtotal = $352,227 )
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	002	6	6/11/2025	EXTENSION WITH OR WITHOUT FUNDS	$35,224
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	6	2/28/2025	EXTENSION WITH OR WITHOUT FUNDS	$317,003
2025	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	001	5	5/2/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $352,227

Issue Date FY: 2024 ( Subtotal = $331,402 )
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	001	5	4/17/2024	NON-COMPETING CONTINUATION	$17,443
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	5	1/4/2024	NON-COMPETING CONTINUATION	$313,959
														Subtotal = $331,402

Issue Date FY: 2023 ( Subtotal = $341,867 )
2023	2023	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	4	1/31/2023	NON-COMPETING CONTINUATION	$341,867
														Subtotal = $341,867

Issue Date FY: 2022 ( Subtotal = $348,844 )
2022	2022	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	3	2/7/2022	NON-COMPETING CONTINUATION	$313,959
2022	2022	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	001	3	5/19/2022	NON-COMPETING CONTINUATION	$34,885
														Subtotal = $348,844

Issue Date FY: 2021 ( Subtotal = $348,844 )
2021	2021	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	2	1/14/2021	NON-COMPETING CONTINUATION	$348,844
														Subtotal = $348,844

Issue Date FY: 2020 ( Subtotal = $348,844 )
2020	2020	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Cancer Detection and Diagnosis Research	000	1	1/1/2020	NEW	$348,844
														Subtotal = $348,844

Grand Total All Awards = $2,388,665

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Circulating Cell-Free DNA as a Personalized Biomarker to Diagnose and Monitor Glioblastoma Extension

Award Number: R37CA246183

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2025

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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