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Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy

Award Number: R01CA218195
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/12/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy - Project Abstract Cervical cancer is a leading cause of cancer-related mortality among women in low- and middle-income countries (LMICs). The World Health Organization recently released guidelines that endorse alternatives to cytology-based screening, including HPV-based screening and visual inspection with acetic acid (VIA), which will facilitate increased screening coverage and detection of curable precursors to cervical cancer. In order to reduce the burden of cervical cancer, highly effective screening strategies must be combined with affordable and accessible treatment of precancerous lesions. The standard treatment for cervical precancer, gas-based cryotherapy, is often not accessible in LMICs because gas tanks are generally expensive, difficult to obtain, and hard to transport. With the number of screening options increasing, an urgent need exists for a point-of- care treatment technology that is accessible, portable, and inexpensive. We innovated the original thermoablator, an existing cervical precancer treatment device with a probe heated to 100-120º C, for use on a wider scale by customizing the device for LMICs in order to meet this need. This academic-industrial partnership will compare this novel device to traditional CO2-based cryotherapy for the treatment of cervical precancer in LMICs. The Specific Aims of this project are to 1) modify a novel thermoablation prototype adapted and optimized specifically for treatment of cervical precancer in LMICs, determine a more nearly optimal patient- centered protocol for treatment of high-grade precancer, demonstrate that the efficacy of LMIC-adapted thermoablator is non-inferior to CO2-based cryotherapy for the treatment of cervical precancer, and determine the cost-effectiveness of all evaluated therapeutic and post-treatment surveillance strategies. The hypothesis being tested is that this novel device is non-inferior to CO2-based cryotherapy in terms of clinical validity and cost- effectiveness. The research team has well-established relationships with leading regional organizations that provide guidance to government-run cervical cancer prevention programs. Deployment of the LMIC-adapted thermoablator to existing programs will not only improve program efficacy, but will also serve as a model for adoption of this technology in the region. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.


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 = -$13,129 )
2026	2023	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE OF CASE WESTERN RESERVE UNIVERSITY	9500 EUCLID AVE.	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	6	11/20/2025	NON-COMPETING CONTINUATION	-$13,129
														Subtotal = -$13,129

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE OF CASE WESTERN RESERVE UNIVERSITY	9500 EUCLID AVE.	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	6	7/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $490,168 )
2023	2023	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE OF CASE WESTERN RESERVE UNIVERSITY	9500 EUCLID AVE.	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	6	6/26/2023	NON-COMPETING CONTINUATION	$490,168
														Subtotal = $490,168

Issue Date FY: 2022 ( Subtotal = $635,825 )
2022	2022	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	001	5	7/8/2022	NON-COMPETING CONTINUATION	$631,938
2022	2021	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	4	1/31/2022	SUPPLEMENT FOR EXPANSION	$3,887
														Subtotal = $635,825

Issue Date FY: 2021 ( Subtotal = $447,581 )
2021	2021	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	001	4	9/13/2021	NON-COMPETING CONTINUATION	$183,207
2021	2021	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	003	4	9/17/2021	SUPPLEMENT FOR EXPANSION	$157,418
2021	2021	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	002	4	9/16/2021	SUPPLEMENT FOR EXPANSION	$106,956
2021	2020	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	3	1/7/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $447,581

Issue Date FY: 2020 ( Subtotal = $897,307 )
2020	2020	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	3	1/14/2020	NON-COMPETING CONTINUATION	$897,307
														Subtotal = $897,307

Issue Date FY: 2019 ( Subtotal = $554,168 )
2019	2019	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	2	1/30/2019	NON-COMPETING CONTINUATION	$485,022
2019	2019	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	001	2	9/10/2019	SUPPLEMENT FOR EXPANSION	$69,146
														Subtotal = $554,168

Issue Date FY: 2018 ( Subtotal = $669,209 )
2018	2018	CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE/CWRU	9500 EUCLID AVE	CLEVELAND	OH	44195	CUYAHOGA	USA	Cancer Detection and Diagnosis Research	000	1	1/12/2018	NEW	$669,209
														Subtotal = $669,209

Grand Total All Awards = $3,681,129

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Comparison of cervical intraepithelial neoplasia 2/3 treatment outcomes with a portable LMIC-adapted thermal ablation device vs. gas-based cryotherapy

Award Number: R01CA218195

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/12/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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