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Identification of biomarker signatures of subtypes of LUTS and their response to treatments using samples from LURN study

Award Number: R01DK125251
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary Lower urinary tract symptoms (LUTS) are costly to treat and significantly affect patients' quality of life. The identification of subtypes of LUTS is critical to the understanding of LUTS pathophysiology and effective clinical management and treatment of patients. Novel tools that can accurately identify the presence, types, and severity of LUTS are needed, and biological markers are one such type of tool. Recent systematic review of biomarkers of LUTS demonstrated the existence of important knowledge gap in published research: poor reproducibility, unclear classification of LUTS patients, and lack of adjustments for clinical covariates. The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was established with the goal of identifying and explaining clinically relevant subtypes of LUTS patients. Over 75,000 biosamples were collected and stored at NIDDK repository, including over 1200 baseline plasma samples for patients and controls, as well as serum samples collected longitudinally for more than 800 patients. We propose to analyze plasma and serum samples collected in LURN to identify biomarker signatures of subtypes of LUTS and their response to treatments. We hypothesize that: (a) subtypes of LUTS will have different biomarker signatures of differentially abundant proteins; (b) biomarker signatures will differ not only across the subtypes of LUTS but also in comparison of improvers and non-improvers; (c) longitudinal changes in biomarker signatures in response to treatment will be different in improvers and non-improvers. Our study consists of three specific aims. Aim 1. To identify protein biomarker signatures contained within plasma of subgroups of men and women with LUTS. We propose to analyze a panel of 1306 proteins using the highly sensitive and reproducible SomaScan assay, which we successfully used in the Biomarker Pilot Project in LURN I. This aim serves to produce comprehensive phenotyping of LUTS by identifying differentially abundant proteins among patients with different subtypes of LUTS. We will build upon the results of LURN I and use biomarker data to refine our previously identified symptom-based subtypes of men and women with LUTS. This is important for better classification, diagnosis, and personalized treatment of patients with LUTS. Aim 2. To identify biomarkers in baseline plasma samples associated with improvement in LUTS. We will use the results of assay performed in Aim 1 to test for significant differences between the biomarker signatures of “best improvers” and “worst non-improvers”. This is of practical importance since it will facilitate early selection of patients who may benefit from more intensive or alternative treatments to LUTS. Aim 3. To quantify longitudinal changes in biomarker signatures within serum of “best improvers” and “worst non-improvers” among men and women with LUTS. Combined with the existing biological knowledge of metabolic and signaling pathway using enrichment analysis this will allow identifying pathways correlated with the improved symptoms and will help in understanding of LUTS pathophysiology and development of better treatments.


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: 2024 ( Subtotal = $0 )
2024	2022	ARBOR RESEARCH COLLABORATIVE FOR HEALTH	3989 RESEARCH PARK DRIVE	ANN ARBOR	MI	48108	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	7/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $213,678 )
2022	2022	ARBOR RESEARCH COLLABORATIVE FOR HEALTH	3700 EARHART ROAD	ANN ARBOR	MI	48105	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	6/8/2022	NON-COMPETING CONTINUATION	$213,678
														Subtotal = $213,678

Issue Date FY: 2021 ( Subtotal = $214,274 )
2021	2021	ARBOR RESEARCH COLLABORATIVE FOR HEALTH	3700 EARHART ROAD	ANN ARBOR	MI	48105	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	5/27/2021	NON-COMPETING CONTINUATION	$214,274
														Subtotal = $214,274

Issue Date FY: 2020 ( Subtotal = $217,655 )
2020	2020	ARBOR RESEARCH COLLABORATIVE FOR HEALTH	3700 EARHART ROAD	ANN ARBOR	MI	48105	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	7/30/2020	NEW	$217,655
2020	2020	ARBOR RESEARCH COLLABORATIVE FOR HEALTH	3700 EARHART ROAD	ANN ARBOR	MI	48105	WASHTENAW	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	9/18/2020	NEW	$0
														Subtotal = $217,655

Grand Total All Awards = $645,607

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Identification of biomarker signatures of subtypes of LUTS and their response to treatments using samples from LURN study

Award Number: R01DK125251

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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