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

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Brief Title

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

Official Title

Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy

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.
    

Detailed Description

      The standard treatment for cervical pre-cancer is gas-based cryotherapy, the freezing of
      tissue to ablate (destroy) lesions. Although cryotherapy is relatively simple to perform, the
      necessary gas tanks are generally expensive, difficult to obtain and transport, and pose a
      danger of explosion. An urgent need exists for a point-of-care treatment technology that is
      accessible, portable, and inexpensive. An alternative ablative procedure in use since the
      1970s is thermoablation (also known as cold coagulation or thermocoagulation), which utilizes
      heat to destroy pre-cancer. Despite its long-standing use, there are no standardized
      guidelines for thermoablation. There is also little data on patient and provider
      acceptability, potential side effects, and the impact of different treatment protocols on
      quality of life. For these reasons, international and national agencies have been hesitant to
      adopt the technique as an alternative to cryotherapy. The purpose of this research study is
      to develop a patient-centered thermoablation protocol that is simple, safe, and effective.

      Currently, the most common treatment technique for thermoablation involves a multiple-tip
      protocol, which uses differently shaped probe-tips to cover the affected area. This technique
      requires a considerable degree of expertise, and may not be the most appropriate strategy for
      settings where highly trained healthcare providers are scarce. In collaboration with WiSAP
      Medical Technology (Brunnthal, Germany), the manufacturer of the most widely used
      thermoablator, the investigators modified the original device to meet the needs of
      low-resource settings. The LMIC-adapted thermoablator is lightweight, portable, and easy to
      operate. The investigators will further modify the LMIC-adapted thermoablator to test the
      non-inferiority of two thermoablation treatment approaches against the standard of care (i.e.
      gas-based cryotherapy). The experimental approaches include:

        1. Single tip: A 19mm conical tip with a nipple is applied to the cervix for 40-seconds at
           100ºC, a single application of which should ablate the squamocolumnar junction (SCJ) in
           the majority of women. In the rare instance that the SCJ is not completely ablated,
           additional 20 second applications can be applied, or

        2. Multiple tips: A narrow nipple shaped tip at 100ºC is placed in the endocervix for 20
           seconds. This is followed by the placement of a 12 mm flat tip at 100ºC on the
           ectocervix for as many 20-second applications as necessary to ablate the entire SCJ.

      These will be tested against traditional CO2 cryotherapy treatment using a MedGyn device in a
      standard double-freeze procedure (3 minute freeze, 5 minute thaw, 3 minute freeze).

      Women will be recruited at colposcopy clinics run by the Ministry of Health and the Mexican
      Institute of Social Security (Instituto Mexicano del Seguro Social) in the Mexico City
      metropolitan region. Eligible women will be those over the age of 18, who are able and
      willing to provide informed consent and a reliable or permanent address, and with a
      biopsy-confirmed CIN2+ diagnosis. Women wo are pregnant, plan to become pregnant during the
      study duration, with a history of total hysterectomy, past surgeries destructive to the
      cervix within the last 5 years, with a disfigure or hard-to-reach cervix, and those with
      contraindications for ablative treatment will be excluded from the study.

      The investigators will approach 1,602 women with CIN2+ during a four-year enrollment phase
      (48 months). Assuming an 80% participation rate, approximately 1,282 women will be enrolled;
      of these, 1,155 (90%) will be eligible for ablation treatment (i.e. no contraindications) and
      129 will be ineligible and undergo alternative treatments (i.e. LEEP or invasive cancer
      treatment). The investigators estimate that approximately 20% will be lost to follow-up at
      the 12-month visit, resulting in complete data on a total of 924 women (57.7% of 1,602)
      treated with CO2-based cryotherapy, single-tip thermoablation, or multiple-tip
      thermoablation. The investigators will monitor the percentages of ineligible women,
      contraindications, and loss to follow-up in real time and adjust recruitment accordingly to
      achieve the target sample size.

      The clinical endpoint of the study will be residual disease at the 12-month follow-up visit
      as determined by colposcopy, four-quadrant biopsy, and endocervical curettage (ECC). HPV
      testing will also be performed at this visit to differentiate between persistent or new
      infection. Cytology, VIA and care HPV tests will also be performed to evaluate the most
      effective post treatment screening strategy.

      At a pre-treatment visit, consented women will receive a pregnancy test as part of the
      eligibility criteria for enrollment in the study. Pre-vaginal cultures will be collected to
      be analyzed for bacterial vaginosis, yeast, gonorrhea and chlamydia. The same cultures will
      be collected at a 6-week follow-up visit. Consented women will be enrolled and undergo a
      pelvic exam and visual inspection of the cervix following placement of diluted acetic acid on
      the cervix. Images of the cervix will be taken with a mobile colposcopy device will be taken
      before and after treatment. Women will be asked to evaluate their pain level after speculum
      insertion, immediately before treatment, and immediately after treatment. These women will
      also complete a quality of life assessment. Women deemed ineligible for cryotherapy will
      undergo LEEP immediately. In the case of suspected cancer, women will be appropriately
      referred.

      Six weeks post-treatment, women who return for a visit for evaluation of treatment side
      effects; these women will be administered a post-treatment patient satisfaction survey, and
      complete a questionnaire to assess the presence of pain or cramps, bleeding, stenosis, watery
      discharge, malodorous discharge and be evaluated for evidence of cervicitis. In addition,
      vaginal cultures will be collected and analyzed for bacterial vaginosis, yeast, gonorrhea,
      and chlamydia.

      One year post-treatment, women will return for a follow-up visit to determine residual
      disease, which is the primary endpoint. Residual disease will be determined by colposcopy and
      four-quadrant biopsies. In addition, VIA, cytology, and high-risk HPV DNA testing with
      careHPV will be performed. Genotyping and next-generation sequencing will be repeated to
      differentiate between persistent and new infections. The investigators will evaluate
      sensitivity of VIA, cytology, and HPV testing post-treatment. Women will be asked to again
      complete the quality of life assessment and treatment acceptability instrument. Women
      diagnosed with recurrent/untreated CIN2+ on biopsy will be asked to return to undergo LEEP.
      Women with suspected cancer on biopsy will be referred to the local cancer hospital for
      standard of care.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Patient's pain assessed using the Wong-Baker FACES scale

Condition

Cervical Intraepithelial Neoplasia

Intervention

Standard C02 Cryotherapy

Study Arms / Comparison Groups

 Standard C02 Cryotherapy
Description:  Standard therapy using carbon dioxide for freezing of tissue

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1282

Start Date

October 30, 2020

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility 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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Miriam Cremer, MD, 216-312-0618, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03429582

Organization ID

17-1385

Secondary IDs

1R01CA218195-01A1

Responsible Party

Sponsor

Study Sponsor

The Cleveland Clinic

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Miriam Cremer, MD, Principal Investigator, The Cleveland Clinic


Verification Date

January 2021