Focal Ablation of Cervical Precancer

February 16, 2018 updated by: University of California, San Francisco

Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of focal treatment
Time Frame: six months
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
Time Frame: 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.
six months
Feasibility of focal treatment
Time Frame: enrollment
Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Karen Smith-McCune, MD, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2013

Primary Completion (Actual)

April 11, 2014

Study Completion (Actual)

May 26, 2014

Study Registration Dates

First Submitted

October 15, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (Estimate)

October 18, 2012

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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