Focal Ablation of Cervical Precancer

High-grade Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

Focal Ablation of High-grade Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709773
• Other study ID #: 12503
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: February 16, 2018
• Start date: January 17, 2013
• Est. completion date: May 26, 2014

Study information

• Verified date: February 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 26, 2014
• Est. primary completion date: April 11, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• High-grade Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Procedure:
• Focal treatment
Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-month recurrence rate of high-grade cervical intraepithelial neoplasia		six months
Secondary	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).	six months
Secondary	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.	six months
Secondary	Feasibility of focal treatment	Providers will be asked to provide information after each treatment regarding whether the treatment was technically feasible to perform.	enrollment