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Plasma miR371 clinical utility and mapping real-world management of testis cancer patients: Extended analysis for clinical utility and secondary use of data of the SWOG 1823/CCTG GCC1 clinical trial

Award Number: R37CA264798
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Plasma miR371 clinical utility and mapping real-world management of testis cancer patients: Extended analysis for clinical utility and secondary use of data of the SWOG 1823/CCTG GCC1 clinical trial - Background. Circulating miR371a-3p (miR371) is a promising biomarker that has demonstrated to have high accuracy to identify clinically detectable active germ cell malignancy (aGCM) in both seminoma and nonseminoma germ cell tumor (GCT) patients. However, its accuracy in detecting sub-clinical or early stage GCT has not been defined yet. S1823 is a SWOG cohort trial that has almost completed its accrual to clinically validate the utility of plasma miR371 to predict/detect aGCM recurrence. Submission of blood specimens for miRNAs analysis and electronical medical reports were mandatory. Therefore, taking advantage of our group leader position in S1823, we are proposing to test a novel and more sensitive methodology to validate the clinical utility of plasma miR371 expression in predicting/detecting aGCM recurrence and to use the rich clinical data of S1823 to analyze the real world pattern of care of testis cancer patients across Canada and USA. Hypothesis. 1. More potent miRNA amplification techniques are more sensitive than RT-PCR to detect few copies of plasma miR371 and therefore will have higher accuracy to detect tumor relapse in CSI GCT patients. 2. Measurable heterogeneity exists in clinical assessments, predictive models, accurate staging and clinical management of GCT patients across the S1823 enrolling centres. Aims. The aims of this research project are: 1. To measure plasma miR371 expression through a new isothermal miRNAs amplification technology, Rolling Circle Amplification (RCA), in patients with low and moderate risk GCT enrolled in the S1823 trial; 2. To map real-world management of testis cancer patients: secondary uses of S1823 data. Methods. For Aim1, plasma miR371 expression and its operating characteristics (positive and negative predictive value, sensitivity, specificity and accuracy), measured by RCA and RT-PCR, in the relapsed patients at the time of relapse and in the relapsed and non-relapsed patients during the follow-up before clinically detectable relapse, will be compared. For Aim2, real world data will be extracted from the S1823 sourced documents. Staging accuracy, risk assessments, timing of treatment, use of adjuvant strategies (surveillance, adjuvant radiation or chemotherapy), dose and field of RT, chemotherapy regimens and number of cycles, use of surgery/RT for primary or residual disease and of standard CT scans or other imaging techniques (FDG-PET scan or MRI) will be evaluated to define the geographic distribution of GCT treatments utilization. Innovation. The integration of miR371 in the clinical management of GCT patients will introduce innovative standard procedures for GCT patients management. miR371 will inform new type and schedule of surveillance, treatment de-escalation and personalization on the base of biological rather than clinical evidence of GCTs. Significance and impact: Knowing the current patterns of care of GCT patients will be useful to draw chemo and radiation therapy prevention strategies based on earlier and more accurate identification of aGCM by miR371. This approach will consequently improve the quality of life and the life expectancy of these patients.


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 = $383,151 )
2026	2026	PROVINCIAL HEALTH SERVICES AUTHORITY	600 10TH AVE W	VANCOUVER	BC			CAN	Cancer Detection and Diagnosis Research	000	4	7/8/2026	EXTENSION WITH OR WITHOUT FUNDS	$383,151
														Subtotal = $383,151

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	PROVINCIAL HEALTH SERVICES AUTHORITY	600 10TH AVE W	VANCOUVER	BC			CAN	Cancer Detection and Diagnosis Research	000	3	5/5/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $371,234 )
2024	2024	PROVINCIAL HEALTH SERVICES AUTHORITY	600 10TH AVE W	VANCOUVER	BC			CAN	Cancer Detection and Diagnosis Research	000	3	4/12/2024	NON-COMPETING CONTINUATION	$371,234
														Subtotal = $371,234

Issue Date FY: 2023 ( Subtotal = $382,956 )
2023	2023	PROVINCIAL HEALTH SERVICES AUTHORITY	600 10TH AVE W	VANCOUVER	BC			CAN	Cancer Detection and Diagnosis Research	000	2	4/4/2023	NON-COMPETING CONTINUATION	$382,956
														Subtotal = $382,956

Issue Date FY: 2022 ( Subtotal = $423,319 )
2022	2022	PROVINCIAL HEALTH SERVICES AUTHORITY	600 10TH AVE W	VANCOUVER	BC			CAN	Cancer Detection and Diagnosis Research	000	1	3/11/2022	NEW	$423,319
														Subtotal = $423,319

Grand Total All Awards = $1,560,660

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Plasma miR371 clinical utility and mapping real-world management of testis cancer patients: Extended analysis for clinical utility and secondary use of data of the SWOG 1823/CCTG GCC1 clinical trial

Award Number: R37CA264798

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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