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Cryotherapy for Human Papillomavirus Clearance in Biopsy-Confirmed Cervical Low-Grade Squamous Intraepithelial Lesions
This study is not yet open for participant recruitment.
Verified by Khon Kaen University, November 2007
Sponsored by: Khon Kaen University
Information provided by: Khon Kaen University
ClinicalTrials.gov Identifier: NCT00566579
  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

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Cryotherapy for Human Papillomavirus Clearance in Biopsy-Confirmed Cervical Low-Grade Squamous Intraepithelial Lesions: a Randomized Controlled Trial

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Human papillomavirus clearance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2007
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
A: Experimental
Cryotherapy
Procedure: Cryotherapy
Double freezing technique
B: No Intervention
Observation

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566579

Contacts
Contact: Bandit Chumworathayi, MD 66818733327 bunchu@kku.ac.th

Locations
Thailand, Khon Kaen
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

The Thailand Research Fund's website  This link exits the ClinicalTrials.gov site

Responsible Party: Faculty of Medicine, Khon Kaen University, Thailand ( Clinical Epidemiology Unit (CEU) )
Study ID Numbers: HE500830
Study First Received: November 30, 2007
Last Updated: November 30, 2007
ClinicalTrials.gov Identifier: NCT00566579  
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Human papillomavirus
Clearance
Cryotherapy

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Diseases
Precancerous Conditions
Cervical intraepithelial neoplasia
Uterine Diseases
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009