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Focal Treatment of High-grade Cervical Intraepithelial Neoplasia


N/A
21 Years
45 Years
Open (Enrolling)
Female
High-grade Cervical Intraepithelial Neoplasia

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Trial Information

Focal Treatment of High-grade Cervical Intraepithelial Neoplasia


Inclusion Criteria:



- Age 21-45 yo

- Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3

- Satisfactory colposcopy, i.e., the entire transformation zone is visible

- Lesion occupying <= 2 quadrants of the cervix.

Exclusion Criteria:

- Unsatisfactory colposcopy.

- Colposcopic lesion extending into the endocervical canal beyond colposcopic
visualization.

- Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.

- Suspicion for invasive cancer on colposcopic exam.

- Glandular dysplasia or atypical glandular cells on cytology.

- Unreliable for follow-up.

- Immunosuppression (HIV, transplant recipient, etc.)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-month recurrence rate of high-grade cervical intraepithelial neoplasia

Outcome Time Frame:

six months

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UCSF_Focaltx

NCT ID:

NCT01709773

Start Date:

April 2013

Completion Date:

March 2015

Related Keywords:

  • High-grade Cervical Intraepithelial Neoplasia
  • Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ

Name

Location

University of California, San FranciscoSan Francisco, California  94143