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

NCT ID: NCT02220192

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

High-grade Cervical Intraepithelial Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Focal LEEP

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Michelle Khan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle J Khan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama of Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

000344450-SP012

Identifier Type: OTHER

Identifier Source: secondary_id

F140613004 (UAB 1425)

Identifier Type: -

Identifier Source: org_study_id