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

NCT02220192 | Completed DMC

• 2 other identifiers: F140613004 (UAB 1425)000344450-SP012
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

High-grade Cervical Intraepithelial Neoplasia

Keywords

cervical neoplasia; cervix; high-grade dysplasia; LEEP (loop electrosurgical excision procedure); precancerous cells; colposcopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Acceptability of focal LEEP procedure

  2 weeks following focal LEEP procedure

• Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia

  Within 1 week following focal LEEP procedure

Study Arms (1)

Focal LEEP

EXPERIMENTAL

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.

Procedure: Focal LEEP

Interventions

Focal LEEP 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.

Focal LEEP

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Study Officials

• Michelle J Khan, MD, MPH

  University of Alabama of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 19, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)