An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure

Not Applicable

Completed

• Conditions: High-grade Cervical Intraepithelial Neoplasia
• Interventions: Procedure: Focal LEEP

• Registration Number: NCT02220192
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This is a pilot study to test the short-term effectiveness of an alternative treatment approach for precancerous cells of the cervix. The study will also explore whether this new treatment is feasible to perform and if it is acceptable to patients.

Detailed Description

Standard treatment for precancerous cells of the cervix is called electrosurgical excision procedure (LEEP). Standard LEEP involves treating the entire cervix using FDA-approved equipment. Focal LEEP utilizes the same surgery and the same equipment but only treats the visually unhealthy part of the cervix and not the entire cervix. Side effects and unusual symptoms will be monitored as well as the patient's thoughts and recommendations of the procedure. The total amount of time of study participation is six months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

Inclusion Criteria

• Age 21-45 years old
• Histologically confirmed high-grade cervical intraepithelial neoplasia (CIN2, CIN3, or CIN2/3). A copy of the pathology report is required at the time of enrollment. We will only include patients that had their biopsy performed at the UAB Colposcopy clinic because those that return for treatment represent a select group that is more reliable for follow-up given the standard no-show rate of 50% at the clinic.
• Focal lesion visualized in its entirety colposcopically and involving less than or equal to 2 quadrants of the cervix.
• Satisfactory (adequate) colposcopy.
• Lives within 100 miles of the University of Alabama at Birmingham.

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Exclusion Criteria

• Any suspicion for invasive cancer.
• Glandular abnormalities on cytology or histology.
• Cervical lesion incompletely visualized (e.g. extending into the endocervical canal).
• Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
• Unreliable for follow-up (drug use, planning to move out of region, etc.). Any patient that lives >100 miles away will be excluded due to concern for possible loss to follow-up.
• Immunosuppression (HIV positive, history of transplantation, lupus on immunosuppressive medication, etc.).
• Pregnancy.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focal LEEP	Focal LEEP	All patients will undergo focal treatment of high-grade cervical intraepithelial neoplasia using LEEP. A two-week follow-up assessment will evaluate the side effects of the treatment and any unusual symptoms. This will be done through a phone survey. At six months a clinic visit is required to assess whether there are any precancerous cells of the patient's cervix.

Primary Outcome Measures

Name	Time	Method
Number of cases of recurrent high-grade cervical intraepithelial neoplasia	6 months	Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.

Secondary Outcome Measures

Name	Time	Method
Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia	Within 1 week following focal LEEP procedure	A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
Acceptability of focal LEEP procedure	2 weeks following focal LEEP procedure	A 15-minute questionnaire will be conducted by phone with the patient.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States