Understanding Extramammary Paget's Disease in Women
Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
This study looks at women with Extramammary Paget's Disease to see how different treatments work and to learn more about the skin and health in those areas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03564483 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women diagnosed with Extramammary Paget's Disease (EMPD) of the vulva and perianal region. It aims to evaluate treatment outcomes while collecting tissue samples and swabs to analyze the microbiome associated with the affected skin areas. Participants will complete various sexual health questionnaires and undergo preoperative genital sensory testing. The study is conducted at the Mayo Clinic, where patients will receive care and may undergo surgical interventions as needed.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 years or older diagnosed with primary or recurrent EMPD of the vulva or perianal region.
Not a fit: Patients who are male or have Paget's Disease in areas other than the vulvar or perianal region may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of EMPD and improve treatment strategies for affected patients.
How similar studies have performed: While there may be limited studies specifically on EMPD, the approach of analyzing the microbiome in relation to skin conditions has shown promise in other dermatological research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females * Age 18 years or older * Diagnosed with primary or recurrent EMPD of vulva and/or perianal region of the body * Willing and able to provide signed informed consent Exclusion Criteria: * Males * Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jamie N. Bakkum-Gamez, M.D. — Mayo Clinic
- Study coordinator: Maureen A. Lemens, R.N.
- Email: lemens.maureen@mayo.edu
- Phone: 507-293-1487
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.