Focal Ablation of Cervical Precancer

Completed · Not applicable

Conditions studied: High-grade Cervical Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT01709773

Run by

University of California, San Francisco

People needed

20

Starts

2013-01-17

Expected to finish

2014-05-26

Last updated by the study team

2018-02-20

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

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.)

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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