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An Innovative Treatment for Cervical Precancer (UH3) (UH3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03084081
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : March 5, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Basic Health International
CryoPen, Inc.
University of Southern California
Albert Einstein College of Medicine
Harvard School of Public Health
Instituto Salvadoreno del Seguro Social
Hospital Universitario San Ignacio
Medical College of Wisconsin
Shanxi Academy of Medical Sciences Shanxi Dayi Hospital
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
The purpose of this academic-industrial partnership will compare the CryoPen® and thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in low and middle income countries (LMICs) and investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Device: CO2 standard therapy Device: CryoPen Device: Thermocoagulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher (CIN2+) Treated With CO2-based Cryotherapy, CropPen, and Thermoablation (UH3)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CO2 standard therapy
Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
Device: CO2 standard therapy
Standard therapy using carbon dioxide for freezing of tissue

Experimental: CryoPen
Single freeze treatment consists of one five-minute freeze
Device: CryoPen
Provides a means of freezing tissue without the use of gases or liquids

Experimental: Thermocoagulator
Thermoablation for 60-seconds at 100 degrees Celsius
Device: Thermocoagulator
Thermoablation




Primary Outcome Measures :
  1. Residual CIN2+ [ Time Frame: 12-months post treatment ]
    Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or with cervical cancer diagnosis


Secondary Outcome Measures :
  1. Pain [ Time Frame: Immediately after treatment ]
    Patient pain scores using the Wong-Baker FACES Pain Rating Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 18 and older
  • Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified
  • Willing and able to provide informed consent
  • Willing and able to provide permanent or reliable address

Exclusion Criteria:

  • Pregnant or plans to become pregnant during study
  • History of total hysterectomy (verified by medical record or pelvic evaluation)
  • Previous surgery destructive to the cervix within the last 5 years
  • Patient not eligible for cryotherapy (lesion >75% of cervix, lesion extends into canal or there is suspicion for invasive cancer)
  • Cervix shape disfigured or hard to reach

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084081


Contacts
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Contact: Miriam Cremer, MD 216-312-0618 cremerm@ccf.org
Contact: Mauricio Maza, MD 503-7854-8873 mmaza@basichealth.org

Locations
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China
Shanxi Academy of Medical Sciences Shanxi Day Hospital Recruiting
Taiyuan, China
Contact: Suhui Wu, MD       shwu1215@163.com   
Colombia
Hospital Universitario San Ignacio Recruiting
Bogota, Colombia
Contact: Raul Murillo, MD       rmurillo@husi.org.co   
El Salvador
Instituto Salvadoreno del Seguro Social (ISSS) Recruiting
San Salvador, El Salvador
Contact: Ana de Uriarte, MD       jginecologia.hlm@isss.gob.sv   
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Basic Health International
CryoPen, Inc.
University of Southern California
Albert Einstein College of Medicine
Harvard School of Public Health
Instituto Salvadoreno del Seguro Social
Hospital Universitario San Ignacio
Medical College of Wisconsin
Shanxi Academy of Medical Sciences Shanxi Dayi Hospital
Investigators
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Principal Investigator: Miriam Cremer, MD The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03084081    
Other Study ID Numbers: 17-294
UH3CA189883 ( U.S. NIH Grant/Contract )
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IDP data will be shared at the completion of the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The Cleveland Clinic:
Human Papilloma Virus (HPV)
Cryotherapy
Thermoablation
Thermocoagulation
Low and Middle Income Countries (LMICs)
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type