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Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.


N/A
18 Years
75 Years
Open (Enrolling)
Female
Vulvar Cancer

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Trial Information

Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.


Inclusion Criteria:



- Patients between the ages 18 and 75 years.

- Patients may be carriers of the Human Immunodeficiency Virus (HIV).

- Patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue
sampling (biopsy-proven vulvar intraepithelial neoplasia grade II or III)

- Patients must be able to come to University Hospital for their initial appointment in
Gynecologic Oncology Clinic, and for the eight follow-up visits in that Clinic
required by the protocol.

Exclusion Criteria:

- Pregnant or patients who are breast feeding a baby.

- Patients who have been diagnosed with a vaginal yeast infection.

- Patients who have undergone prior surgery for precancerous lesion(s) of the vulva.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Principal Investigator

Bernadette Cracchiolo, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Medicine and Dentistry New Jersey

Authority:

United States: Institutional Review Board

Study ID:

0120050348

NCT ID:

NCT00382330

Start Date:

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • Vulva
  • Vulvar Neoplasms

Name

Location

University of Medicine and Dentistry of NJNewark, New Jersey  07107