Focal Ablation of Cervical Precancer

University of California San Francisco (UCSF)

Status: Completed

Conditions: High-grade Cervical Intraepithelial Neoplasia

Treatments: Procedure: Focal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01709773

12503

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Focal treatment arm

Experimental group

Treatment:

Procedure: Focal treatment