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Focal Ablation of Cervical Precancer

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ClinicalTrials.gov Identifier: NCT01709773
Recruitment Status : Unknown
Verified August 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2012
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
High-grade Cervical Intraepithelial Neoplasia Procedure: Focal treatment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
Study Start Date : April 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.


Eligibility Criteria

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

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709773


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01709773     History of Changes
Other Study ID Numbers: UCSF_Focaltx
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type