Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01145781
Other study ID # 649
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2010
Est. completion date January 2015

Study information

Verified date April 2018
Source Tata Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 64 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
India Tata Memorial Hospital Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary end point is the cure rate at the end of one year The primary end point is the cure rate at the end of one year by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze. 1 year
Secondary The secondary end points are the rates and the types of side effects and complications The secondary end points are the rates and the types of side effects and complications by comparing between two different techniques of cryotherapy i.e. single freeze and double freeze. 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Completed NCT02907333 - Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia N/A
Recruiting NCT02576262 - HPV Integration Testing for Human Papillomavirus-Positive Women N/A
Completed NCT01029990 - Randomized Controlled Trial to Study Interventions to Increase Participation in Cervical Cancer Screening Program Phase 0
Recruiting NCT05078528 - Low-cost Imaging Technology for Global Prevention of Cervical Cancer N/A
Recruiting NCT05502367 - A Study of ABI-2280 Vaginal Tablet in Participants With Cervical Intraepithelial Neoplasia Phase 1/Phase 2
Completed NCT02494310 - HRME: Screening for Cervical Cancer and Its Precursors in Low‐Resource Settings N/A
Active, not recruiting NCT03429582 - Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device N/A
Active, not recruiting NCT02140021 - Biospecimen Collection and Testing for the Prevalence of Anal Dysplasia and Anal Cancer in Patients With Cervical, Vaginal and Vulvar Dysplasia and Cancer N/A
Not yet recruiting NCT05510830 - Diagnostic Cervical Conization for Persistent Infection or Integration of HPV N/A
Completed NCT02237326 - Visual Inspection With Acetic Acid Compared to Lugol's Iodine in HIV-infected Women N/A
Completed NCT00316706 - Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine Phase 3
Withdrawn NCT03143491 - Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN) Phase 2
Completed NCT03293628 - Comparing Two Techniques of Haemostasis After Cervical Conization Phase 2
Recruiting NCT05266898 - Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV Phase 4
Completed NCT02481414 - A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions Phase 2
Completed NCT02247999 - Improving Cervical Cancer Screening Among HIV-Infected Women in India
Recruiting NCT04646954 - DNA Methylation Testing for the Screening of Uterine Cervical Lesion Phase 3
Recruiting NCT04650711 - Immunohistochemical Staining of p16 for the Screening of Cervical Cancer Phase 2
Completed NCT01544478 - V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110) Phase 4