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Development, field testing and evaluation of the efficacy of a hand-held, portable and affordable thermo-coagulator to prevent cervical cancer in low- and middle-income countries

Award Number: UH3CA202721
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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DESCRIPTION (provided by applicant): Successful cervical precancer screening programmes have not been replicated widely in Low and Middle Income Countries (LMICs) for a variety of reasons but largely due to the expense of laboratory based tests and colposcopy. Instead screen and treat programmes have been established relatively widely. These programmes are not trouble or cost free but are relatively inexpensive and successful. The most commonly used combination is Visual Inspection with Acetic acid (VIA) to screen and cryocautery to treat. Both of these have disadvantages. VIA overcalls abnormality relatively frequently and cryocautery is fraught with difficulties in gas (CO2 or N2O) supply both because it is variably expensive, variably available and difficult to transport. Furthermore the long treatment time of cryocautery (11minutes in total) is perceived as a relative problem compared to Thermal Coagulation (1 - 2 mins) or LLETZ (1-2 minutes). Aims : This project aims to improve screen and treat programmes by discovering the best method of treatment and by reducing the treatment of normal women. The specific aims are 1. To develop, test and produce 200 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah). 2. To evaluate the success / failure rate of Thermal Coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to Large Loop Excision of the Transformation Zone (LLETZ aka LEEP) as part of a screen and treat programme in Zambia. 3. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia. 4. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases. 5. To determine the value of Z scan to predict normality and abnormality in VIA positive women randomly assigned to excisional therapy Methods : In collaboration with a medical devices company in Utah, we will develop and test the engineering performance of the Liger Thermal Coagulator in vitro and in vivo. We will produce 200+ Liger units and undertake a randomised controlled trial of the device compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy will allow us to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women


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 = -$6,943 )
2024	2023	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	25 AVE TONY GARNIER	LYON				FRA	Cancer Treatment Research	000	5	7/12/2024	SUPPLEMENT FOR EXPANSION	-$6,943
														Subtotal = -$6,943

Issue Date FY: 2023 ( Subtotal = $442,901 )
2023	2023	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Treatment Research	000	5	12/2/2022	SUPPLEMENT FOR EXPANSION	$442,901
2023	2023	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	25 AVE TONY GARNIER	LYON				FRA	Cancer Treatment Research	002	5	8/22/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	25 AVE TONY GARNIER	LYON				FRA	Cancer Cause and Prevention Research	001	5	8/22/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $442,901

Issue Date FY: 2022 ( Subtotal = $442,901 )
2022	2022	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Cause and Prevention Research	003	5	9/9/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2022	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Cause and Prevention Research	000	5	1/28/2022	SUPPLEMENT FOR EXPANSION	$442,901
2022	2021	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Detection and Diagnosis Research	002	5	9/9/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Cause and Prevention Research	001	5	9/9/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $442,901

Issue Date FY: 2021 ( Subtotal = $350,000 )
2021	2021	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON				FRA	Cancer Detection and Diagnosis Research	000	5	6/4/2021	SUPPLEMENT FOR EXPANSION	$350,000
														Subtotal = $350,000

Issue Date FY: 2020 ( Subtotal = $489,630 )
2020	2020	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON		69008		FRA	Cancer Cause and Prevention Research	000	5	7/29/2020	NON-COMPETING CONTINUATION	$489,630
														Subtotal = $489,630

Issue Date FY: 2019 ( Subtotal = $938,485 )
2019	2019	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON		69008		FRA	Cancer Cause and Prevention Research	002	4	9/5/2019	NON-COMPETING CONTINUATION	$719,063
2019	2019	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON		69008		FRA	Cancer Detection and Diagnosis Research	001	3	3/18/2019	SUPPLEMENT FOR EXPANSION	$212,479
2019	2018	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON		69008		FRA	Cancer Cause and Prevention Research	000	3	1/7/2019	EXTENSION WITH OR WITHOUT FUNDS	$6,943
														Subtotal = $938,485

Issue Date FY: 2018 ( Subtotal = $513,260 )
2018	2018	CENTRE INTERNATIONAL DE RECHERCHE SUR LE CANCER	150 COURS ALBERT THOMAS	LYON		69008		FRA	Cancer Cause and Prevention Research	000	3	9/17/2018	EXTENSION WITH OR WITHOUT FUNDS	$513,260
														Subtotal = $513,260

Grand Total All Awards = $3,170,234

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Development, field testing and evaluation of the efficacy of a hand-held, portable and affordable thermo-coagulator to prevent cervical cancer in low- and middle-income countries

Award Number: UH3CA202721

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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