Mohs surgery for female genital Paget's disease: a prospective observational trial.
Kelly H Bruce, Toni P Kilts, Mary E Lohman...
https://pubmed.ncbi.nlm.nih.gov/37633576Actively Recruiting
Age: 18Years +
FEMALE
ID03564483
Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
Led by Mayo Clinic · Updated on 2026-01-28
100
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research aims to better understand Extramammary Paget's Disease (EMPD), focusing on women with vulvar or perianal Paget's disease. The study will collect tissue samples and swabs to explore the microorganisms (microbiome) living on or near affected skin areas. Researchers want to learn more about treatment outcomes and disease characteristics in this specific group. Participants will be identified during visits to the Dermatology or Gynecologic Surgery departments at Mayo Clinic. They will undergo cultures of skin, rectum, and vagina to analyze the microbiome. Women will follow a care pathway including dermatology consultations, preoperative genital sensory testing, and possibly Moh's micrographic surgery or excisional procedures by gynecologic surgery. Samples such as swabs, urine, and tissue will be collected before interventions for further analysis. During the study, participants will complete various sexual health and quality of life questionnaires. They will be monitored for outcomes including long-term survival over 25 years. The study collects data through physical exams, questionnaires, tissue sampling, and clinical follow-up. This observational registry aims to gather comprehensive information on EMPD in women, supporting better understanding and care.
CONDITIONS
Brief Title
Gynecologic Extramammary Paget's Disease
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Females
- Age 18 years or older
- Diagnosed with primary or recurrent Extramammary Paget's Disease of the vulva and/or perianal region
- Willing and able to provide signed informed consent
You will not qualify if you...
- Males
- Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Initial visit at presentation
Participants undergo physical exams and sample collections including skin, rectum, and vagina cultures to assess the microbiome. They complete various sexual health questionnaires and receive genital sensory testing to measure sensation in the clitoris, vulva, and vagina.
1 visit (in-person)
Monitoring
Duration - Up to 25 years
Participants are observed as they follow the established care pathway for Extramammary Paget's Disease, including Dermatology consultations and possible Moh's micrographic procedures. If surgical intervention is chosen, participants undergo excisional surgery with tissue, urine, and swabs collected for microbiome analysis prior to procedures.
Follow-up visits as part of routine care and monitoring over time
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
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Research Team
M
Maureen A. Lemens, R.N.
K
Karen P Ishitani, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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