Focal Ablation of Cervical Precancer
This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Focal Ablation of High-grade Cervical Intraepithelial Neoplasia|
- Six-month recurrence rate of high-grade cervical intraepithelial neoplasia [ Time Frame: six months ] [ Designated as safety issue: Yes ]
- Safety of focal treatment [ Time Frame: six months ] [ Designated as safety issue: Yes ]Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).
- Acceptability of focal treatment [ Time Frame: six months ] [ Designated as safety issue: No ]Participants will be asked to respond to a survey at enrollment and follow-up asking whether they are satisfied with focal treatment as an alternative method of treatment.
- Feasibility of focal treatment [ Time Frame: enrollment ] [ Designated as safety issue: No ]Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Focal treatment arm||
Procedure: Focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709773
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94109|
|Principal Investigator:||Karen Smith-McCune, MD, PhD||University of California, San Francisco|