Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia

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Brief Title

Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia

Official Title

Randomised Intervention Trial to Evaluate Single- and Double- Freeze Cryotherapy in the Prevention of Cervical Neoplasia

Brief Summary

      To evaluate whether single- and double-freeze cryotherapy techniques have similar efficacy in
      controlling different grades of cervical intraepithelial neoplasia (CIN), and have similar
      side effects and complications.
    

Detailed Description

      Healthy women aged 25 to 64 yrs with histology confirmed ectocervical CIN lesions confined to
      ectocervix without extension to endocervix or vagina will be randomized to single- or
      double-freeze cryotherapy, as per the inclusion criteria will be invited to participate in
      the study.

      They will be explained about the study. Informed consent will be obtained from each recruited
      woman. The cases selected with lesions that can be adequately covered with largest cryo probe
      (2.5 cm diameter) will be randomized between the following arms.

      Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze
      technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.

      The patients will be advised about excessive discharge per vagina for 4 weeks and mild
      abdominal cramps.

      They will be advised to abstain from sexual intercourse for 6 weeks. They would be followed
      up after one month for clinical evaluation and at 12th month to determine the cure rates by
      Pap test, HPV Test and colposcopy with or without biopsy.

      The reference investigations to determine cure rates at the end of 12 months would be Pap
      smear, HPV Testing by HC II and colposcopy with or with out biopsy which will be offered to
      all the participants and biopsy will be done on women with colposcopic abnormalities.

      Randomized trial: Stratified by lesion. Randomisation and analysis will be stratified on the
      grades of CIN.

      Randomisation process:

      Each woman eligible for cryotherapy who presents for treatment, will be allocated a
      randomisation number.

      This randomisation number is a 4 digit number: The first digit represent the CIN stage (1, 2
      or 3), the 3 next digits are the sequential number of the patient (from 001 to 999). Each
      sequential number is randomly attributed to a treatment arm. The table containing this
      information will be kept by the principal investigator and is only known by the people
      involved in the treatment.

      The arm the patient has been randomised to will not be known by the people performing the
      follow-up visit in order to avoid any reporting bias. As soon as the patient has been
      randomised to double- or single-freeze, the box corresponding to the sequential number line
      and the CIN column will be marked with 'X'. The randomisation protocol will be rigorously
      followed.

      Women with biopsy proven ASCUS-H and CIN lesion, after obtaining an informed consent will be
      randomized between single and double freeze treatment cases. The first follow-up is after one
      month and the next at 12th month, where patient would be subjected to Pap test, HPV Test by
      Hybrid Capture II and colposcopy with or without biopsy.
    


Study Type

Interventional


Primary Outcome

The primary end point is the cure rate at the end of one year

Secondary Outcome

 The secondary end points are the rates and the types of side effects and complications

Condition

Cervical Intraepithelial Neoplasia

Intervention

Cryotherapy

Study Arms / Comparison Groups

 Single-freeze cryotherapy
Description:  Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw.

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

Procedure

Estimated Enrollment

440

Start Date

January 2010

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility Criteria

        Inclusion Criteria Apparently healthy women aged 25 to 64 yrs with following criteria will
        be eligible to participate in the study.

          1. Histological confirmation of ASCUS -H, CIN I, CIN II and CIN III lesions.

          2. The lesion confined to ecto cervix only.

          3. No obvious cervical and vaginal infection.

          4. Women in proliferative phase of menstrual cycle or post menopausal cases.

          5. Negative endo cervical curettage.

        Exclusion criteria Women less than 25 and more than 64 years will not be enrolled.
      

Gender

Female

Ages

25 Years - 64 Years

Accepts Healthy Volunteers

No

Contacts

Gauravi A MIshra, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01145781

Organization ID

649


Responsible Party

Principal Investigator

Study Sponsor

Tata Memorial Hospital


Study Sponsor

Gauravi A MIshra, MD, Principal Investigator, Tata Memorial Hospital


Verification Date

April 2018