Status:
COMPLETED
An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
High-grade Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
21-45 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02220192
Start Date
December 1 2014
End Date
March 1 2016
Last Update
April 6 2016
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294