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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Tata Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01145781
First received: June 16, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Cervical Intraepithelial Neoplasia
Procedure: Cryotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: RANDOMISED INTERVENTION TRIAL TO EVALUATE SINGLE- AND DOUBLE- FREEZE CRYOTHERAPY IN THE PREVENTION OF CERVICAL NEOPLASIA

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • The primary end point is the cure rate at the end of one year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary end points are the rates and the types of side effects and complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 440
Study Start Date: January 2010
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single-freeze cryotherapy
Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw.
Procedure: Cryotherapy
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.
Active Comparator: Double-freeze cryotherapy
Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
Procedure: Cryotherapy
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145781

Contacts
Contact: Gauravi A Mishra, MD +91-22-24157532 gauravi2005@yahoo.co.in
Contact: Sharmila A Pimple, MD +91-22-24154379 drsharmilapatil@yahoo.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, Maharashtra, India
Contact: Gauravi A Mishra, MD    +91-22-24157532    gauravi2005@yahoo.co.in   
Contact: Sharmila A Pimple, MD    +91-22-24154379    drsharmilapatil@yahoo.com   
Principal Investigator: Gauravi A Mishra, MD         
Principal Investigator: Sharmila A Pimple, MD         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Gauravi A MIshra, MD Tata Memorial Hospital
Principal Investigator: Sharmila A Pimple, MD Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01145781     History of Changes
Other Study ID Numbers: 649
Study First Received: June 16, 2010
Last Updated: June 16, 2010
Health Authority: India:Tata Memorial Hospital

Keywords provided by Tata Memorial Hospital:
ectocervical CIN lesions

Additional relevant MeSH terms:
Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 28, 2014