Safety and efficacy of the new CryoPop\xae cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls

S Yogeshkumar ,Yogendra M Kabadi,Vijayalaxmi Patil,Amit Revankar,Richard Derman,Aruna Biradar,Surekha Hipparagi,Shivaprasad S Goudar ,Gayane Yenokyan,Laxmikant Lokare,Hema Patil,Margaret Mensa,Mrutyunjaya Bellad ,Mahantesh B Nagmoti ,Edward Kenyi,B R Patil ,Enriquito Lu,Ramadevi Wani,Ramalingappa Antartani,Santosh Chikaraddi ,Sunita S Vernekar ,Katrina Thaler,Jean Anderson,M R Gudadinni ,Purushotham Reddy,Ranjit Kangle,Ramesh Chavan ,Kasturi V Donimath ,Shailaja R Bidri ,Anita Dalal

doi:10.1186/s13063-021-05802-8

Abstract

BackgroundCervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions.MethodsThis study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers, and potential participants. Organized community based as well as hospital-based screening is being conducted using visual inspection with acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high-grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device.DiscussionThere is a need to develop an inexpensive, simple, and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment.Trial registrationClinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644. Registered on November 6, 2019.

Highlights

Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries
An overwhelming majority (90%) of cervical cancer deaths occur in low- and middle-income countries (LMICs), with only 5% of global cancer resources allotted to these settings
Cervical cancer is relatively unique in that there is a recognizable pre-invasive phase in which progression from oncogenic strains of human papilloma virus (HPV) infection—the primary causative agent of cervical cancer—to invasive disease evolves over several years, passing through distinct precancerous phases known as cervical dysplasia or squamous intraepithelial lesions

Summary

Methods

This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers, and potential participants. Organized community based as well as hospital-based screening is being conducted using visual inspection with acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high-grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device

Discussion

Background

Methods/design

Findings