Observational study for patients with early stage squamous cell cancer of the vulva

What we are studying

In patients with a new diagnosis of vulvar cancer, it is likely that the cancer does not spread to lots of lymph nodes at once, but instead the cancer may spread to just one or two lymph nodes first, before moving on to affect others. These first nodes are called the ‘sentinel nodes’. We would like to investigate whether the current treatment options we are using can improve the treatment of women with this disease. Prior to recent studies from both the United States and Europe, patients with vulvar cancer would undergo removal of several lymph nodes in their groin region. Additional radiotherapy with or without chemotherapy would be prescribed if the lymph nodes were involved with disease. More recently, sentinel lymph node removal has been shown to adequately predict lymph node spread. There are fewer side-effects with sentinel node dissection when compared to the older operation in which all lymph nodes were removed. We would like to prospectively observe patients who receive radiation +/- chemotherapy immediately after sentinel lymph node dissection to confirm the safety of this procedure. Avoiding extensive removal of lymph nodes may reduce the side effects for these women. Your treatment will be decided by your treating physician and we will collect details of your treatment We would also like to continue to collect information about the treatment and outcomes for those women who are found not to have disease spread to the sentinel lymph node(s). If you are in this group (the majority of patients) we will not remove any further lymph nodes but instead will monitor you closely to ensure the treatment has been effective.

Who we are studying

  • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Diagnosis of squamous cell carcinoma

What is involved

  • After standard of care treatment participants will be followed closely with visits to the office every 2 months for 2 years

Contact Information

Study Coordinator
Melissa Swain, RN
Email
mswain@wakehealth.edu
Phone
336-716-9428

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.