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Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device

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: NCT03429582
Recruitment Status : Not yet recruiting
First Posted : February 12, 2018
Last Update Posted : July 28, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Basic Health International
WISAP Medical Technologies GMBH
University of Southern California
Albert Einstein College of Medicine
Medical College of Wisconsin
Peking University Shenzhen Hospital
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
The purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will 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: Standard C02 Cryotherapy Device: Single Tip Thermoablation Device: Multiple Tip Thermoablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard C02 Cryotherapy
Standard therapy using carbon dioxide for freezing of tissue
Device: Standard C02 Cryotherapy
Standard therapy using carbon dioxide for freezing of tissue

Experimental: Single Tip Thermoablation
Thermoablator outfitted with a 19mm conical tip
Device: Single Tip Thermoablation
Thermoablator outfitted with a 19mm conical tip

Experimental: Multiple Tip Thermoablation
Thermoablator outfitted with detachable probes
Device: Multiple Tip Thermoablation
Thermoablator outfitted with detachable probes




Primary Outcome Measures :
  1. Residual CIN2+ diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or with cervical cancer diagnosis Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or with cervical cancer diagnosis [ Time Frame: 12-months post treatment ]
    To compare CIN2+ cure rates 12-months post-treatment for CO2-based cryotherapy and both single versus multiple tips thermoablation strategies


Secondary Outcome Measures :
  1. Patient's pain assessed using the Wong-Baker FACES scale [ Time Frame: Immediately after speculum insertion, immediately before treatment, and immediately after treatment ]

    Functional Assessment of Chronic Illness Therapy for Patients with Cervical Dysplasia Version 4 (FACIT-CD). Consists of 5-subscales listed below. For all subscales and the scale, 0 is the worst outcome, higher scores are better outcomes. All subscales are summed.

    Subscale ranges are as follows: Physical well-being:0 to 32, Treatment satisfaction:0 to 16, General perceptions:0 to 28, Emotional well-being:0 to 44, Relationship support: 0 to 16 Wong-Baker FACES® Pain Rating Scale, construct being measured is pain for anyone over the age of 3. Scale range: Minimum = 0, Maximum = 10. For each scale range, what is a better or worse outcome: 0 is a better outcome (no pain), higher scores are worse outcomes, and 10 is the worst outcome (worst pain). There are no subscales.



Other Outcome Measures:
  1. Patient's satisfaction with treatment assessed with the FACIT-CD questionnaire (FACIT Measurement System) [ Time Frame: At enrollment, 6-week visit, and 12-month follow-up visit ]
    FACIT-CD Version 4: 5-subscales. For all subscales and the scale, 0 is the worst outcome, higher scores are better outcomes. All subscales are summed. Subscale ranges are as follows: Physical well-being:0 to 32, Treatment satisfaction: 0 to 16, General perceptions: 0 to 28, Emotional well-being:0 to 44, Relationship support: 0 to 16

  2. Patient's hope for the future using the Herth Hope Index [ Time Frame: At enrollment and at 12-month follow-up visit ]
    Herth Hope Index. The construct is hope in adults in clinical settings. Scale ranges: 1 to 4. For the total index, 12 is the worst outcome. Higher scores are better outcomes. There are no subscales.



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

Criteria for inclusion

  • 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

Criteria for exclusion

  • 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 or thermoablation (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): NCT03429582


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
Peking University Shenzhen Hospital
Shenzhen, China
Contact: Ruifang Wu, MD    86-13827433039    wurf100@126.com   
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Basic Health International
WISAP Medical Technologies GMBH
University of Southern California
Albert Einstein College of Medicine
Medical College of Wisconsin
Peking University Shenzhen Hospital
Investigators
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Principal Investigator: Ruifang Wu, MD Peking University Shenzhen Hospital
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03429582    
Other Study ID Numbers: 17-1385
1R01CA218195-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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