Clinical trial NCT02220192: An Alternative Treatment for Cervical Intraepithelial Neoplasia Using the Focal Loop Electrosurgical Excision Procedure
Official title: Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-grade Cervical Intraepithelial Neoplasia
Keywords: cervical neoplasia
cervix
high-grade dysplasia
LEEP (loop electrosurgical excision procedure)
precancerous cells
colposcopy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-19
Enrollment: 11
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of cases of recurrent high-grade cervical intraepithelial neoplasia
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of focal LEEP procedure
timeFrame: 2 weeks following focal LEEP procedure
measure: Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia
timeFrame: Within 1 week following focal LEEP procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama of Birmingham
name: Michelle J Khan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: