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| ID | Type | Description | Link |
|---|---|---|---|
| 000344450-SP012 | Other Identifier | Office of Sponsored Programs |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of focal LEEP procedure | A 15-minute questionnaire will be conducted by phone with the patient. | 2 weeks following focal LEEP procedure |
| Feasibility of focal LEEP of high-grade cervical intraepithelial neoplasia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle J Khan, MD, MPH | University of Alabama of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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A short feasibility questionnaire will be completed by the medical provider performing the focal LEEP procedure.
| Within 1 week following focal LEEP procedure |