Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions

This study has been terminated.
(Lack of additional funding)
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00566579
First received: November 30, 2007
Last updated: August 2, 2010
Last verified: December 2007
  Purpose

Persistent human papillomavirus (HPV) infections is the single necessary cause of cervical cancer. Cervical cancer is still the major health problem in the developing countries. It has been the first rank women's cancer in Thailand for many decades. Approximately 10-20% of Thai women have the high-risk HPV (HR-HPV) infections in their cervices. This will frequently lead to low-grade squamous intraepithelial lesions (LSILs) (10%), high-grade squamous intraepithelial lesions (HSILs) (0.8%), and finally, cervical cancers (0.16%) within 10-20 years. The treatment options for LSILs are either observation or ablative surgery. However, in our institute, cryotherapy, which is the one of ablative surgery, is more frequently used to comfort our women. It is not only effective but safe with only minimal side effects; watery leukorrhea for 2-4 weeks, and local cervical infection not more than 1%. Contraindication to this procedure are active cervical infection, lesion of 2 mm-larger than probe, lesion inside cervical os and suspected cervical cancer. Additionally, in developing countries such as Thailand, this treatment is safe, acceptable, feasible and effective. Patients with LSILs could also have this treatment in some rural area from the 10-days trained nurses. Fortunately, recent reports showed that cryotherapy has abilities not only in clearing LSILs but also clearing the HPV infections, its necessary cause. However, there are no randomized controlled trial compared its clearing ability between observation and cryotherapy. Therefore, a randomized controlled trial is needed to demonstrate that. Findings from this trial will contribute enormously to older women who already get infected by HPV. Aside from preventing cervical cancer in treated woman, cryotherapy could also give her relief from worrying about having a time-bomb like HPV infection in her cervix.


Condition Intervention
Human Papillomavirus Clearance at 12 Months
Procedure: Cryotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cryotherapy for Human Papillomavirus Clearance in Biopsy-confirmed Cervical Low-grade Squamous Intraepithelial Lesions: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Number of Patients With Human Papillomavirus Clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At 12 months after treatment, a patient with negative results for HPV testing of previous types was considered as a clearance.


Enrollment: 100
Study Start Date: December 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
Procedure: Cryotherapy
Double freezing technique
Other Name: Cryosurgery
No Intervention: B
Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Biopsy-confirmed LSIL patients
  • Age more than 30 years-old
  • Baseline HPV testing is positive.
  • Be able to give their informed consent to this study.

Exclusion Criteria:

  • Having active cervical infection
  • Having lesion of 2 mm-larger than probe
  • Having lesion inside cervical os
  • Having suspected cervical cancer lesion
  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: NCT00566579

Locations
Thailand
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Muang, Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Bandit Chumworathayi, MD Gynecologic Oncology Division, OBGYN Department, Faculty of Medicine, Khon Kaen University
  More Information

Additional Information:
No publications provided by Khon Kaen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Epidemiology Unit (CEU), Faculty of Medicine, Khon Kaen University, Thailand
ClinicalTrials.gov Identifier: NCT00566579     History of Changes
Other Study ID Numbers: HE500830
Study First Received: November 30, 2007
Results First Received: June 1, 2010
Last Updated: August 2, 2010
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Human papillomavirus
Clearance
Cryotherapy

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 26, 2014