Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]

NCT04154644 | Completed DMC

• 1 other identifier: 1UH3CA189923-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Globally, cervical cancer is the second most common cancer for women and kills approximately 250,000 women every year, with the annual number of deaths expected to increase to 410,000 by 2030. The majority (88%) of these deaths occur in low- and middle-income countries (LMICs) where screening and prevention services are limited. Prevention of cervical cancer by identification and treatment of cervical cancer precursors is key, since treatment resources for invasive disease are scarce. A cervical cancer screening program cannot be effective unless it is linked with a proven intervention to prevent the development of cervical cancer. The World Health Organization (WHO) recently released the WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, which recommends a screen-and-treat approach for cervical cancer prevention, with cryotherapy being the first choice of treatment for women who have a positive screen. However, these programs are still slow to be implemented in part due to the current high cost and low efficiency of cryotherapy equipment that is often prone to breaking. Jhpiego, an affiliate of Johns Hopkins University (JHU), has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current equipment while also ten times more efficient. Once proven safe, feasible and effective, CryoPop could save tens of thousands of lives in low- and middle-income countries each year by preventing cervical cancer.

Conditions

Cervical Dysplasia

Keywords

Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant.

  The proportion of pap smears and colposcopy/biopsies that are negative (have no dysplasia or cancer) as confirmed by Pap smear and/or biopsy read by 2 or 3 pathologists. If there is discordance between the Pap and biopsy readings, the reading with the greater abnormality will have priority as an endpoint.

  6 months

Secondary Outcomes (1)

• Safety of CryoPop: Incidences of adverse events documented throughout the study.

  6 months

Study Arms (1)

Cervical Cytology

EXPERIMENTAL

100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device

Device: CryoPop

Interventions

CryoPop DEVICE

The new CryoPop device will be tested on women with abnormal cytology. Benchmark testing occurred in the previous study and CryoPop was found to be non-inferior to standard cryotherapy device (MedGyn) in woman with normal cytology.

Cervical Cytology

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be 30-49 years old
• High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology
• Eligible for cryotherapy based on size of lesion (occupies \<75% of cervix) and fully visible on colposcopy or visual inspection with acetic acid (VIA)
• Willing and able to provide consent.

You may not qualify if:

• Menopausal
• History of hysterectomy
• Known HIV+ or active cervical infections
• Lesion occupies \>75% of cervix and/or extends into the endo cervical canal
• Pregnancy

Sponsors & Collaborators

• Jhpiego: lead
• Jawaharlal Nehru Medical College: collaborator

Study Sites (1)

JN Medical College

Belagavi, Karnataka, 590010, India

Location

Related Publications (9)

• Thomas G. Are we making progress in curing advanced cervical cancer? J Clin Oncol. 2011 May 1;29(13):1654-6. doi: 10.1200/JCO.2010.34.1966. Epub 2011 Mar 28. No abstract available.

  PMID: 21444860 BACKGROUND

• Sawaya GF, Grimes DA. New technologies in cervical cytology screening: a word of caution. Obstet Gynecol. 1999 Aug;94(2):307-10. doi: 10.1016/s0029-7844(99)00289-6.

  PMID: 10432148 BACKGROUND

• van der Graaf Y, Klinkhamer PJ, Vooijs GP. Effect of population screening for cancer of the uterine cervix in Nijmegen, The Netherlands. Prev Med. 1986 Nov;15(6):582-90. doi: 10.1016/0091-7435(86)90063-0.

  PMID: 3797390 BACKGROUND

• Sankaranarayanan R, Rajkumar R, Esmy PO, Fayette JM, Shanthakumary S, Frappart L, Thara S, Cherian J. Effectiveness, safety and acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening study in India. Br J Cancer. 2007 Mar 12;96(5):738-43. doi: 10.1038/sj.bjc.6603633. Epub 2007 Feb 20.

  PMID: 17311015 BACKGROUND

• Nene BM, Hiremath PS, Kane S, Fayette JM, Shastri SS, Sankaranarayanan R. Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical intraepithelial neoplasia in Maharashtra, India. Int J Gynaecol Obstet. 2008 Dec;103(3):232-6. doi: 10.1016/j.ijgo.2008.07.016. Epub 2008 Sep 24.

  PMID: 18817909 BACKGROUND

• Sauvaget C, Muwonge R, Sankaranarayanan R. Meta-analysis of the effectiveness of cryotherapy in the treatment of cervical intraepithelial neoplasia. Int J Gynaecol Obstet. 2013 Mar;120(3):218-23. doi: 10.1016/j.ijgo.2012.10.014. Epub 2012 Dec 22.

  PMID: 23265830 BACKGROUND

• Santesso N, Mustafa RA, Wiercioch W, Kehar R, Gandhi S, Chen Y, Cheung A, Hopkins J, Khatib R, Ma B, Mustafa AA, Lloyd N, Wu D, Broutet N, Schunemann HJ. Systematic reviews and meta-analyses of benefits and harms of cryotherapy, LEEP, and cold knife conization to treat cervical intraepithelial neoplasia. Int J Gynaecol Obstet. 2016 Mar;132(3):266-71. doi: 10.1016/j.ijgo.2015.07.026. Epub 2015 Nov 28.

  PMID: 26643302 BACKGROUND

• Quentin W, Adu-Sarkodie Y, Terris-Prestholt F, Legood R, Opoku BK, Mayaud P. Costs of cervical cancer screening and treatment using visual inspection with acetic acid (VIA) and cryotherapy in Ghana: the importance of scale. Trop Med Int Health. 2011 Mar;16(3):379-89. doi: 10.1111/j.1365-3156.2010.02722.x. Epub 2011 Jan 9.

  PMID: 21214692 BACKGROUND

• Yogeshkumar S, Anderson J, Lu E, Kenyi E, Mensa M, Thaler K, Antartani R, Donimath K, Patil B, Chikaraddi S, Bidri S, Biradar A, Gudadinni MR, Lokare L, Yenokyan G, Bellad MB, Goudar SS, Derman R, Revankar A, Patil H, Wani R, Kangle R, Chavan RY, Nagmoti MB, Kabadi YM, Reddy P, Vernekar S, Hipparagi S, Patil V, Dalal A. Safety and efficacy of the new CryoPop(R) 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. Trials. 2021 Dec 13;22(1):915. doi: 10.1186/s13063-021-05802-8.

  PMID: 34903244 DERIVED

Related Links

• WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Anderson, MD

  janders@jhmi.edu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 6, 2019
• Study Start: April 9, 2019
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)