High-grade Cervical Intraepithelial Neoplasia
Conditions
Keywords
cervical neoplasia, cervix, high-grade dysplasia, LEEP (loop electrosurgical excision procedure), precancerous cells, colposcopy
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.
Interventions
PROCEDUREFocal 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.
Sponsors
National Cancer Institute (NCI)
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases of recurrent high-grade cervical intraepithelial neoplasia | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of focal LEEP procedure | 2 weeks following 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 | Within 1 week following focal LEEP procedure | A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure. |
Countries
United States
Outcome results
None listed