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Clinical study to evaluate the methylation signature of head and neck squamous cell carcinoma pain

Award Number: K23DE030250
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 08/01/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Clinical study to evaluate the methylation signature of head and neck squamous cell carcinoma pain - ABSTRACT The proposed research and career development plan have been designed to facilitate my path toward becoming an independent surgeon scientist focused on highly translational head and neck squamous cell carcinoma (HNSCC) research. I have devoted my early research career to exploring epigenetic mechanisms (i.e., DNA methylation) of HNSCC pain, an area of research that has otherwise gone unnoticed. This proposal builds on my previous research in which I determine that hypermethylation of pain-mediating genes contribute to HNSCC pain in patients, and that hypomethylating agents treat HNSCC pain. The career development plan is carefully structured to hone my expertise in clinical research through a series of courses, national meetings, and meetings with my mentorship team. Upon completion of the K23, I will be well-prepared to apply for independent research funding through an R01 mechanism, which will support my translational research program focused on treatments for head and neck cancer pain. In this proposal I take a systematic approach to identify genes that are methylated in patients with severe HNSCC pain. In Aim 1 I prospectively enroll HNSCC patients, quantify their pain levels with validated pain questionnaires, and collect their cancer tissue for analysis with a genome-wide methylation array. I will analyze the methylation data and identify a suite of hypermethylated genes in patients with severe pain. I have proven feasibility of this approach through preliminary studies, in which I used existing methylation data in HNSCC patients to identify a list of hypermethylated genes. Many of these genes have not previously been associated with pain processing. In Aim 2, I focus on one hypermethylated gene and determine whether adenovirus therapy to re-express the gene produces antinociception in the preclinical model. The project is impactful because it explores a pain mechanism that is largely unknown. The results will establish the methylation signature of HNSCC pain. These genes could be targeted with either gene therapy or hypomethylating agents to treat HNSCC pain, offering non-opioid alternatives and making the research clinically relevant, especially with the current opioid crisis. My mentorship and advisory team is comprised of individuals who have expert knowledge in all aspects of translational and clinical research, specifically in the areas of cancer, pain, bioinformatics, and drug discovery, all of which are critical for the proposed research. I receive protected time, laboratory space, start-up funding, and personnel support. The career development plan and proposed research will bring me closer to realizing my career goal of developing highly effective treatments for head and neck cancer pain.


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: 2025 ( Subtotal = $173,016 )
2025	2025	LOMA LINDA UNIVERSITY	11145 ANDERSON ST STE 203	LOMA LINDA	CA	92350	SAN BERNARDINO	USA	Oral Diseases and Disorders Research	000	5	7/24/2025	NON-COMPETING CONTINUATION	$173,016
														Subtotal = $173,016

Issue Date FY: 2024 ( Subtotal = $173,016 )
2024	2024	LOMA LINDA UNIVERSITY	11145 ANDERSON ST	LOMA LINDA	CA	92350	SAN BERNARDINO	USA	Oral Diseases and Disorders Research	000	4	7/30/2024	NON-COMPETING CONTINUATION	$173,016
														Subtotal = $173,016

Issue Date FY: 2023 ( Subtotal = $173,016 )
2023	2023	LOMA LINDA UNIVERSITY	11060 ANDERSON ST BLDG MAGAN HALL	LOMA LINDA	CA	92350	SAN BERNARDINO	USA	Oral Diseases and Disorders Research	000	3	8/24/2023	NON-COMPETING CONTINUATION	$173,016
														Subtotal = $173,016

Issue Date FY: 2022 ( Subtotal = $173,016 )
2022	2022	LOMA LINDA UNIVERSITY	11060 ANDERSON ST BLDG MAGAN HALL	LOMA LINDA	CA	92350	SAN BERNARDINO	USA	Oral Diseases and Disorders Research	000	2	7/15/2022	NON-COMPETING CONTINUATION	$173,016
														Subtotal = $173,016

Issue Date FY: 2021 ( Subtotal = $173,016 )
2021	2021	LOMA LINDA UNIVERSITY	11060 ANDERSON ST BLDG MAGAN HALL	LOMA LINDA	CA	92350	SAN BERNARDINO	USA	Oral Diseases and Disorders Research	000	1	7/15/2021	NEW	$173,016
														Subtotal = $173,016

Grand Total All Awards = $865,080

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Clinical study to evaluate the methylation signature of head and neck squamous cell carcinoma pain

Award Number: K23DE030250

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 08/01/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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