Globally, cervical cancer is the second most common cancer in women and kills approximately 250,000 women every year, with the annual number of deaths expected to increase to 410,000 by 2030.1,2 The majority (88%) of these deaths occur in low- and middle- income countries (LMICs) where screening and prevention services are limited. 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, has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current equipment while also ten times more efficient. Jhpiego proposes to work closely with colleagues at The Cancer Institute Foundation, Inc. for Moving as One at the University of the Philippines to conduct a study on the performance, safety, and efficacy of the device for cervical dysplasia in LMIC settings.
For Aim 1, to assess performance, the study will compare the depth and width of necrosis between standard cryotherapy and CryoPop in premenopausal women aged 30-49 who are undergoing a planned total hysterectomy.
In Aim 2, the safety of the device will be determined among a small sample of women who have abnormal cervical cytology and to ensure there are no serious adverse events related to cryotherapy performed with CryoPop. If successful, a clinical trial to document effectiveness of the device (UH3) in treatment of precancerous lesions will be performed at the same site. Women who present with abnormal cervical cytology will be randomly assigned to either CyroPop or cryotherapy. The study will compare the proportion of women who have negative cytology at 6 and 12 months of follow-up between the CryoPop and standard cryotherapy arms for equivalence. 1 Sexual and Reproductive Health: Cancer of the Cervix. World Health Organization. Retrieved November 27, 2012, from www.who.int/reproductivehealth/topics/cancers/en/index.html 2 Thomas G. Are We Making Progress in Curing Advanced Cervical Cancer? Journal of Clinical Oncology. 2011;29(13): 1654-6 3 WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, 2013

Public Health Relevance

Jhpiego, an affiliate of Johns Hopkins University, 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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Exploratory/Developmental Cooperative Agreement Phase I (UH2)
Project #
1UH2CA189923-01
Application #
8789615
Study Section
Special Emphasis Panel (ZCA1-SRLB-R (M1))
Program Officer
Jessup, John M
Project Start
2014-09-22
Project End
2019-08-31
Budget Start
2014-09-22
Budget End
2015-08-31
Support Year
1
Fiscal Year
2014
Total Cost
$490,004
Indirect Cost
$76,637
Name
Johns Hopkins University
Department
None
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218