Study for Paget's Disease of the Vulva

Overseen By Karen P Ishitani, RN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Males, Paget's Disease elsewhere

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8-12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about a rare skin condition called Extramammary Paget's Disease (EMPD), which affects areas like the vulva and perianal region. Researchers will collect tissue samples and swabs from participants to study the disease and the tiny organisms (microbiome) living on the skin. This study targets women diagnosed with primary or recurring EMPD in these specific areas. Participants must consent to sample collection.

As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to a better understanding and treatment of EMPD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Why are researchers excited about this trial?

Researchers are excited about the trial for Gynecologic Extramammary Paget's Disease because it explores new diagnostic methods that could improve treatment precision. Unlike traditional approaches, which typically rely on visible examination and biopsy, this trial investigates the use of swab and tissue sample collection to potentially identify the disease more accurately and earlier. This could lead to more targeted and effective treatment plans, ultimately improving patient outcomes and quality of life.

Who Is on the Research Team?

Jamie N. Bakkum-Gamez, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

Females

Diagnosed with primary or recurrent EMPD of vulva and/or perianal region of the body

Willing and able to provide signed informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Patients undergo physical exams, skin/rectum/vagina cultures, and complete sexual health questionnaires

4-6 weeks

1-2 visits (in-person)

Treatment

Patients may undergo preoperative genital sensory testing, Dermatology consultation, and Moh's micrographic procedure, followed by excisional surgery if indicated

8-12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for surgical outcomes, morbidity, recurrence, and long-term survival

25 years

What Are the Treatments Tested in This Trial?

Interventions

• Swab Collection
• Tissue Sample Collection

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+