Safety and efficacy of the new CryoPop® 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.

Autor:	Yogeshkumar S; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Anderson J; Department of Obstetrics and Gynecology, Johns Hopkins University, School of Medicine, Baltimore, USA., Lu E; Jhpiego, an Affiliate of Johns Hopkins University, Baltimore, USA., Kenyi E; Jhpiego, an Affiliate of Johns Hopkins University, Baltimore, USA. Edward.Kenyi@jhpiego.org., Mensa M; Jhpiego, an Affiliate of Johns Hopkins University, Baltimore, USA., Thaler K; Department of Obstetrics and Gynecology, Johns Hopkins University, School of Medicine, Baltimore, USA., Antartani R; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Donimath K; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Patil B; Karnataka Cancer Therapy & Research Institute, Hubballi, Karnataka, India., Chikaraddi S; Karnataka Cancer Therapy & Research Institute, Hubballi, Karnataka, India., Bidri S; BLDE (Deemed to be University) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India., Biradar A; BLDE (Deemed to be University) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India., Gudadinni MR; BLDE (Deemed to be University) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India., Lokare L; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Yenokyan G; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA., Bellad MB; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Goudar SS; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Derman R; Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, USA., Revankar A; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Patil H; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Wani R; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Kangle R; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Chavan RY; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Nagmoti MB; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India., Kabadi YM; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Reddy P; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Vernekar S; Karnataka Institute of Medical Sciences, Hubballi, Karnataka, India., Hipparagi S; BLDE (Deemed to be University) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India., Patil V; BLDE (Deemed to be University) Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India., Dalal A; Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, India.
Jazyk:	angličtina
Zdroj:	Trials [Trials] 2021 Dec 13; Vol. 22 (1), pp. 915. Date of Electronic Publication: 2021 Dec 13.
DOI:	10.1186/s13063-021-05802-8
Abstrakt:	Background: Cervical 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. 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: There 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 Registration: Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644 . Registered on November 6, 2019. (© 2021. The Author(s).)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu Plný text ve formátu PDF