June 19, 2006
Women Sought for Study Involving Rare Cancer
NEWARK — Researchers at UMDNJ-New Jersey Medical School are seeking women with vulvar dysplasia, more commonly known as precancerous vulvar lesions, to participate in a study that will determine the effectiveness of an FDA-approved topical cream called ciclopirox lotion.
The two-year study, which is funded by a grant from the New Jersey Commission on Cancer Research, calls for participants to apply the cream to their vulva three times a day for 13 weeks. During that period, the women will be examined bi-weekly to observe whether the lesions have reduced, enlarged or remained the same size.
“Vulvar dysplasia is an uncommon condition that can have a huge impact on a woman’s life,” says Bernadette Cracchiolo, MD, MPH, FACOG, the principal investigator of the study and director of the Division of Gynecologic Oncology at New Jersey Medical School. “If left untreated, it may lead to cancer of the vulva.”
“Women who have vulvar dysplasia can be treated by having the lesions removed surgically or by laser,” says Cracchiolo, but this can be very painful and lead to scarring of the vulva. “We hope that using ciclopirox lotion will eliminate or reduce the size of the abnormality making the surgery less extensive or unnecessary.”
“With more research, however, we hope the need for surgery will be eliminated,” added Cracchiolo who is also an assistant professor at New Jersey Medical School.
Symptoms for vulvar dysplasia include persistent vaginal itching and white or gray patches on the vulva. In addition, approximately 75 percent of the women with vulvar dysplasia have been diagnosed with the human papillomavirus (HPV).
According to Cracchiolo, a vulvar dysplasia diagnosis can only be obtained by a biopsy.
“It’s also critical that women have regular pap smears and an examination of the vulva to detect any irregularities, ” she said.
Vulvar dysplasia is usually completely curable with proper treatment, but if left untreated, can develop into vulvar cancer in a minority of overall cases. While vulvar cancer is rare and the exact number of cases is unknown, it is estimated that over 3,000 women in the United States develop this type of cancer each year. Since 1980, the number of vulvar cancer cases has almost doubled and is becoming more common among younger women.
Participants in the study must be 18 or older and cannot be pregnant. HIV positive women may also participate if not eligible for anti-retroviral therapy. All participants who complete the study will be reimbursed a total of $500, which is paid in increments throughout the study.
For more information or to enroll in the study, please call (973) 972-5554.
UMDNJ is the nation’s largest free-standing public health sciences university with more than 5,500 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health, on five campuses. Last year, there were more than two million patient visits to UMDNJ facilities and faculty at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level 1 Trauma Center in Newark, and University Behavioral HealthCare, a mental health and addiction services network.