Focal Ablation of Cervical Precancer

Not Applicable

Completed

• Conditions: High-grade Cervical Intraepithelial Neoplasia
• Interventions: Procedure: Focal treatment

• Registration Number: NCT01709773
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Study Start: 2013-01-17
• Primary Completion: 2014-04-11
• Study Completion: 2014-05-26
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal treatment arm	Focal treatment	-

Primary Outcome Measures

Name	Time	Method
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia	six months

Secondary Outcome Measures

Name	Time	Method
Feasibility of focal treatment	enrollment	Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
Safety of focal treatment	six months	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	six months	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States