Focal Ablation of Cervical Precancer

Study Overview
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Brief Summary
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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.

Official Title
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Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

Conditions
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High-grade Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: Focal treatment


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focal treatment arm<br> | Procedure: Focal treatment<br>* Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-month recurrence rate of high-grade cervical intraepithelial neoplasia |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of focal treatment | Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS). | six months | 
| Acceptability of focal treatment | 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. | six months | 
| Feasibility of focal treatment | Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform. | enrollment |