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 (DELTA)

• ClinicalTrials.gov Identifier: NCT02956239
• Recruitment Status: Active, not recruiting
• First Posted: November 6, 2016
• Last Update Posted: March 3, 2023
• Sponsor: International Agency for Research on Cancer
• Collaborators: University of North Carolina Global Project Zambia; Liger Medical Llc
• Information provided by (Responsible Party): Partha Basu, International Agency for Research on Cancer

Study Description

Brief Summary:

This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.

Condition or disease	Intervention/treatment	Phase
Cervical Precancer	Procedure: Thermocoagulation (device); Procedure: Cryotherapy (device); Procedure: LEEP (device)	Not Applicable

Detailed Description:

This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are

1. To develop, test and produce 20 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

In collaboration with a medical devices company in Utah, the engineering performance of the Liger Thermal Coagulator has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 1, 2017
• Estimated Primary Completion Date: August 31, 2023
• Estimated Study Completion Date: September 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Thermocoagulation (device); VIA Positive women will be treated by the new device for thermocoagulation	Procedure: Thermocoagulation (device); Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: Cryotherapy (device); VIA positive women will be treated by cryotherapy	Procedure: Cryotherapy (device); Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
Active Comparator: LEEP (device); VIA Positive women not suitable for thermo-coagulation or cryotherapy will be treated by LEEP	Procedure: LEEP (device); The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit

Outcome Measures

Primary Outcome Measures :

1. Difference in proportions with no lesions at 12 months follow-up between the thermocoagulation and cryotherapy arms among VIA positive women treated at baseline [ Time Frame: 12 months ]
   The VIA positive women will be followed up after 12 months to see if the lesions have disappeared. HPV test will be used as the test of cure

Secondary Outcome Measures :

1. Over-treatment defined as the number of VIA positive women found with no CIN lesions in the post-operative LEEP specimens [ Time Frame: 12 months ]
   The LEEP specimens will be subjected to histopathology to check for presence of cervical intraepithelial neoplasias

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 49 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Positive on VIA test for cervical cancer screening
• Eligible for ablative treatment

Exclusion Criteria:

• Pregnancy
• Not voluntarily willing to participate

Contacts and Locations

Locations

Zambia

UNC Global Project Zambia

Lusaka, Zambia

Sponsors and Collaborators

International Agency for Research on Cancer

University of North Carolina Global Project Zambia

Liger Medical Llc

Investigators

• Principal Investigator: Partha Basu, Dr; IARC

More Information

Publications:

Pinder LF, Parham GP, Basu P, Muwonge R, Lucas E, Nyambe N, Sauvaget C, Mwanahamuntu MH, Sankaranarayanan R, Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2020 Jan;21(1):175-184. doi: 10.1016/S1470-2045(19)30635-7. Epub 2019 Nov 14.

Mwanahamuntu M, Kapambwe S, Pinder LF, Matambo J, Chirwa S, Chisele S, Basu P, Prendiville W, Sankaranarayanan R, Parham GP. The use of thermal ablation in diverse cervical cancer "screen-and-treat" service platforms in Zambia. Int J Gynaecol Obstet. 2022 Apr;157(1):85-89. doi: 10.1002/ijgo.13808. Epub 2021 Jul 31.

• Responsible Party: Partha Basu, Early Detection, Prevention and Infection Branch at IARC, WHO, International Agency for Research on Cancer
• ClinicalTrials.gov Identifier: NCT02956239
• Other Study ID Numbers: 1UH2CA202721-01 ( U.S. NIH Grant/Contract )
• First Posted: November 6, 2016
• Last Update Posted: March 3, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Partha Basu, International Agency for Research on Cancer:

cervical precancer; screening; treatment; thermo-coagulation; thermal ablation; Reducing overtreatment

Additional relevant MeSH terms:

Uterine Cervical Dysplasia; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Precancerous Conditions