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Focal Ablation of Cervical Precancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: October 15, 2012
Last updated: August 7, 2014
Last verified: August 2014
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.

Condition Intervention
High-grade Cervical Intraepithelial Neoplasia Procedure: Focal treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Six-month recurrence rate of high-grade cervical intraepithelial neoplasia [ Time Frame: six months ]

Secondary Outcome Measures:
  • 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).

  • 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.

  • 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.

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Focal treatment arm Procedure: Focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure


Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01709773

United States, California
University of California, San Francisco
San Francisco, California, United States, 94109
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Karen Smith-McCune, MD, PhD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco Identifier: NCT01709773     History of Changes
Other Study ID Numbers: UCSF_Focaltx
Study First Received: October 15, 2012
Last Updated: August 7, 2014

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on September 21, 2017