This trial is active, not recruiting.

Condition high-grade cervical intraepithelial neoplasia
Treatment focal treatment
Sponsor University of California, San Francisco
Start date April 2013
End date December 2014
Trial size 40 participants
Trial identifier NCT01709773, UCSF_Focaltx


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure

Primary Outcomes

Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
time frame: six months

Secondary Outcomes

Safety of focal treatment
time frame: six months
Acceptability of focal treatment
time frame: six months
Feasibility of focal treatment
time frame: enrollment

Eligibility Criteria

Female participants from 21 years up to 45 years old.

Inclusion Criteria: - Age 21-45 yo - Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3 - Satisfactory colposcopy, i.e., the entire transformation zone is visible - Lesion occupying <= 2 quadrants of the cervix. Exclusion Criteria: - Unsatisfactory colposcopy. - Colposcopic lesion extending into the endocervical canal beyond colposcopic visualization. - Endocervical curettage positive for high-grade cervical intraepithelial neoplasia. - Suspicion for invasive cancer on colposcopic exam. - Glandular dysplasia or atypical glandular cells on cytology. - Unreliable for follow-up. - Immunosuppression (HIV, transplant recipient, etc.)

Additional Information

Official title Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
Principal investigator Karen Smith-McCune, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.