Focal Treatment of High-grade Cervical Intraepithelial Neoplasia
N/A
21 Years
45 Years
21 Years
45 Years
Open (Enrolling)
Female
High-grade Cervical Intraepithelial Neoplasia
Female
High-grade Cervical Intraepithelial Neoplasia
Trial Information
Focal Treatment of High-grade Cervical Intraepithelial Neoplasia
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.)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
Outcome Time Frame:
six months
Safety Issue:
Yes
Authority:
United States: Institutional Review Board
Study ID:
UCSF_Focaltx
NCT ID:
NCT01709773
Start Date:
April 2013
Completion Date:
March 2015
Related Keywords:
- High-grade Cervical Intraepithelial Neoplasia
- Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ
Name | Location |
|---|---|
| University of California, San Francisco | San Francisco, California 94143 |
