Focal Treatment of Cervical Precancer
This study is not yet open for participant recruitment.
Verified October 2012 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
Michelle Khan, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01709773
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
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Purpose
This will be a pilot cohort study of women undergoing focal treatment for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort will be recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria will be recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they will undergo focal treatment rather than standard treatment of the cervix. Follow-up visits will be 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 Treatment 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: | January 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709773
Contacts
| Contact: Michelle Khan, MD, MPH | 415-443-6662 | KhanM@globalhealth.ucsf.edu |
Locations
| United States, California | |
| University of California, San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94109 | |
Sponsors and Collaborators
University of California, San Francisco
More Information
No publications provided
| Responsible Party: | Michelle Khan, Clinical Instructor, 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: | October 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 21, 2013