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Completed

NCT Number: NCT02220192

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

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.

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 19, 2014
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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