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

Primary Purpose

High-grade Cervical Intraepithelial Neoplasia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Focal LEEP

About this trial

This is an interventional treatment trial for High-grade Cervical Intraepithelial Neoplasia focused on measuring cervical neoplasia, cervix, high-grade dysplasia, LEEP (loop electrosurgical excision procedure), precancerous cells, colposcopy

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal LEEP

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability of focal LEEP procedure

A 15-minute questionnaire will be conducted by phone with the patient.

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.

Full Information

NCT ID

NCT02220192

First Posted

August 7, 2014

Last Updated

April 5, 2016

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02220192

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-grade Cervical Intraepithelial Neoplasia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Focal LEEP

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Focal LEEP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of cases of recurrent high-grade cervical intraepithelial neoplasia

Description

Recurrence of high-grade cervical intraepithelial neoplasia will be determined from cytologic and/or histologic evidence collected six months following the focal LEEP procedure.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Acceptability of focal LEEP procedure

Description

A 15-minute questionnaire will be conducted by phone with the patient.

Time Frame

2 weeks following focal LEEP procedure

Title

Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia

Description

A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.

Time Frame

Within 1 week following focal LEEP procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle J Khan, MD, MPH

Organizational Affiliation

University of Alabama of Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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