Focal Ablation of Cervical Precancer
Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedStudy Start
First participant enrolled
January 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2014
CompletedFebruary 20, 2018
February 1, 2018
1.2 years
October 15, 2012
February 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
six months
Secondary Outcomes (3)
Safety of focal treatment
six months
Acceptability of focal treatment
six months
Feasibility of focal treatment
enrollment
Study Arms (1)
Focal treatment arm
EXPERIMENTALInterventions
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94109, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Smith-McCune, MD, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 18, 2012
Study Start
January 17, 2013
Primary Completion
April 11, 2014
Study Completion
May 26, 2014
Last Updated
February 20, 2018
Record last verified: 2018-02