Focal Ablation of Cervical Precancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01709773
First received: October 15, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of focal treatment [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01709773     History of Changes
Other Study ID Numbers: UCSF_Focaltx
Study First Received: October 15, 2012
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014