High-grade Cervical Intraepithelial Neoplasia
Conditions
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.
Interventions
PROCEDUREFocal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-month recurrence rate of high-grade cervical intraepithelial neoplasia | six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of focal treatment | 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 | 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 | enrollment | Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform. |
Countries
United States
Outcome results
None listed