Back to resultsFocal Ablation of Cervical Precancer
Primary Purpose
High-grade Cervical Intraepithelial Neoplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focal treatment
Sponsored by
About this trial
This is an interventional treatment trial for High-grade Cervical Intraepithelial Neoplasia
Eligibility 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.)
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Focal treatment arm
Arm Description
Outcomes
Primary Outcome Measures
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
Secondary Outcome Measures
Safety of focal treatment
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
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
Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
Full Information
NCT ID
NCT01709773
First Posted
October 15, 2012
Last Updated
February 16, 2018
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01709773
Brief Title
Focal Ablation of Cervical Precancer
Official Title
Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 17, 2013 (Actual)
Primary Completion Date
April 11, 2014 (Actual)
Study Completion Date
May 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-grade Cervical Intraepithelial Neoplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focal treatment arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Focal treatment
Intervention Description
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Primary Outcome Measure Information:
Title
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
Time Frame
six months
Secondary Outcome Measure Information:
Title
Safety of focal treatment
Description
Participants will be asked to report any adverse events following focal treatment. These events will be graded according to standard criteria (DAIDS).
Time Frame
six months
Title
Acceptability of focal treatment
Description
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.
Time Frame
six months
Title
Feasibility of focal treatment
Description
Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.
Time Frame
enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Smith-McCune, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Focal Ablation of Cervical Precancer
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