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

High-grade Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220192
• Other study ID #: F140613004 (UAB 1425)
• Secondary ID: 000344450-SP012
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: April 5, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• High-grade Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Acceptability of focal LEEP procedure	A 15-minute questionnaire will be conducted by phone with the patient.	2 weeks following focal LEEP procedure	Yes
Secondary	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	No