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