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Optimizing Ultrasensitive DNA methylation detection for lung cancer and other malignancies

Award Number: U2CCA271885
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2022
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Optimizing Ultrasensitive DNA methylation detection for lung cancer and other malignancies - This proposal for a Biomarker Characterization Center (BCC) for the Early Detection Research Network (EDRN) seeks to improve the management of lung cancer through detection of cancer- specific DNA methylation. This effort includes a Biomarker Development Laboratory (BDL) which will optimize the methylation detection methods, implementation of these methods for clinical use through a Biomarker Reference Laboratory (BRL) with a longstanding record of molecular testing in a clinical setting, and an Administrative Core facilitating the interactions between the BDL and BRL, and with other EDRN investigators and the NCI. Previous work by the applicants has demonstrated the potential of DNA methylation detection for cancer diagnostics, and they have developed extremely sensitive assays for the detection of hypermethylated DNA sequences and optimized the isolation and processing of circulating cell-free DNA from tumors for these novel assays. The approach has been used to detect circulating cancer-specific DNA methylation changes for the early diagnosis of lung cancer in patients with screen-detected pulmonary nodules. Although sensitivity and specificity of the assay are promising, additional improvements in the performance are required for implementation of this approach in the setting of cancer screening. In this BCC, detection of cancer-specific DNA methylation changes in the plasma will be further improved, and new approaches developed and implemented to address the challenges of ultrasensitive detection of DNA methylation in the blood. In addition, we will assess the potential of these methods to detect other common and lethal malignancies. Our bioinformatic analysis of DNA methylation from The Cancer Genome Atlas (TCGA) has identified novel highly frequent cancer-specific methylation events common to all cancers, including lung cancer, that will be developed into universal cancer detection assays. The use of TCGA data has also resulted in the identification of other methylation alterations that allow determination of the origin (organ site) of this cancer-specific signal. The combination of optimal sample processing, ultrasensitive methylation detection, developed with universal cancer and histology specific loci detection, will allow improved lung cancer early detection in the setting of CT screening and management of detection of other cancer-specific DNA methylation from blood.


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 = $517,300 )
2026	2026	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	5	8/26/2026	NON-COMPETING CONTINUATION	$517,300
														Subtotal = $517,300

Issue Date FY: 2025 ( Subtotal = $807,262 )
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	4	8/22/2025	NON-COMPETING CONTINUATION	$807,262
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	3	4/25/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	3	2/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $807,262

Issue Date FY: 2024 ( Subtotal = $846,821 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	003	3	8/15/2024	NON-COMPETING CONTINUATION	$0
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	002	3	8/7/2024	NON-COMPETING CONTINUATION	$846,821
2024	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	2	8/5/2024	NON-COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	2	2/13/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $846,821

Issue Date FY: 2023 ( Subtotal = $879,659 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	001	2	8/8/2023	NON-COMPETING CONTINUATION	$879,659
2023	2022	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	1	12/6/2022	NEW	$0
														Subtotal = $879,659

Issue Date FY: 2022 ( Subtotal = $658,591 )
2022	2022	UNIVERSITY OF PITTSBURGH, THE	4200 5TH AVE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Cancer Detection and Diagnosis Research	000	1	9/16/2022	NEW	$658,591
														Subtotal = $658,591

Grand Total All Awards = $3,709,633

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Optimizing Ultrasensitive DNA methylation detection for lung cancer and other malignancies

Award Number: U2CCA271885

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/16/2022

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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