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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220192
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michelle Khan, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
High-grade Cervical Intraepithelial Neoplasia Procedure: Focal LEEP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focal Loop Electrosurgical Excision Procedure for High-Grade Cervical Intraepithelial Neoplasia: an Alternative Treatment Approach
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Focal LEEP
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
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 Measures :
  1. Number of cases of recurrent high-grade cervical intraepithelial neoplasia [ Time Frame: 6 months ]
    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 :
  1. Acceptability of focal LEEP procedure [ Time Frame: 2 weeks following focal LEEP procedure ]
    A 15-minute questionnaire will be conducted by phone with the patient.

  2. Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia [ Time Frame: Within 1 week following focal LEEP procedure ]
    A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220192


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michelle J Khan, MD, MPH University of Alabama of Birmingham
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Responsible Party: Michelle Khan, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02220192    
Other Study ID Numbers: F140613004 (UAB 1425)
000344450-SP012 ( Other Identifier: Office of Sponsored Programs )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michelle Khan, University of Alabama at Birmingham:
cervical neoplasia
cervix
high-grade dysplasia
LEEP (loop electrosurgical excision procedure)
precancerous cells
colposcopy
Additional relevant MeSH terms:
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Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type