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

Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach

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.

Study Overview

• Status: Completed
• Conditions: High-grade Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Procedure: Focal LEEP

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Focal LEEP; Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michelle J Khan, MD, MPH, University of Alabama of Birmingham

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 18, 2014
• First Posted (Estimate): August 19, 2014

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: colposcopy; cervical neoplasia; cervix; high-grade dysplasia; LEEP (loop electrosurgical excision procedure); precancerous cells
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ; Cervical Intraepithelial Neoplasia
• Other Study ID Numbers: F140613004 (UAB 1425); 000344450-SP012 (Other Identifier: Office of Sponsored Programs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO