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

Completed · Not applicable

Conditions studied: High-grade Cervical Intraepithelial Neoplasia

In brief

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.

Key facts

Study ID

NCT02220192

Run by

University of Alabama at Birmingham

People needed

11

Starts

2014-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-04-06

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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