Gynecologic Extramammary Paget's Disease

Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease

In addition to evaluating treatment outcomes, tissue samples and swabs will be collected as part of this study to allow physicians to better understand Extramammary Paget's Disease (EMPD). The researchers also want to learn more about the microorganisms (microbiome) that live on or near the areas of skin affected by EMPD, in order to better understand this condition.

Study Overview

• Status: Recruiting
• Conditions: Extramammary Paget Disease; Paget Disease, Extramammary; Extramammary Paget's Disease; Extramammary Paget's Disease of Vulva (Diagnosis); Extramammary Paget's Disease of Vagina (Diagnosis); Extramammary Paget's Disease Vulva Invasive; Extramammary Paget's Disease of Anus (Diagnosis); Extramammary Paget's Disease of Anal Canal (Diagnosis); Extramammary Paget's Disease of Skin

Detailed Description

This is a prospective cohort study. Patients with Extramammary Paget's Disease (EMPD), specifically women with vulvar/perianal Paget's disease, will be identified during presentation to either the Dermatology Department or Gynecologic Surgery department at Mayo Clinic.

During physical exam, the patients will undergo skin/rectum/vagina cultures to evaluate the microbiome in these patients. The patients will be entered into the established care pathway for EMPD. They will be asked to complete sexual health questionnaires including: The Women's Health Clinical Questionnaires include the Menopause Rating Scale (MRS)1, Perceived Stress Scale2, Brief Resilience Scale (BRS)3, LASA Quality of Life Assessment4, Female Sexual Function Index (FSFI)5, Female Sexual Distress Scale-Revised6, Kansas Marital Satisfaction Scale7, and Pittsburgh Sleep Quality Index (PSQI)8.

The patients will be referred to Women's Health Clinic as part of the care pathway and will undergo preoperative genital sensory testing (GST) which measures sensation of the clitoris, vulva, and vagina. The patients will have a Dermatology consultation and Moh's micrographic procedure as indicated. If choosing to proceed with surgical intervention, the patients will then undergo an excisional procedure with the Department of Gynecologic surgery. Swabs, urine and tissue will be collected prior to procedures or surgery for microbiome analysis.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Maureen A. Lemens, R.N.; Phone Number: 507-293-1487; Email: lemens.maureen@mayo.edu
• Study Contact Backup: Name: Karen P Ishitani, RN; Phone Number: 507-538-5355; Email: ishitani.karen@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Maureen A. Lemens, R.N.; Phone Number: 507-293-1487; Email: lemens.maureen@mayo.edu
      • Contact: Karen P Ishitani, RN; Phone Number: 507-538-5355; Email: ishitani.karen@mayo.edu
      • Principal Investigator: Jamie N. Bakkum-Gamez, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with Extramammary Paget's Disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Registry Observational Study; All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).	Prospective data including patient demographic information, surgical outcomes, surgical morbidity, recurrence, and long-term survival in extramammary Paget's disease (EMPD) will be collected as part of this registry..	25 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Jamie N. Bakkum-Gamez, M.D., Mayo Clinic

Publications and helpful links

General Publications

• Bruce KH, Kilts TP, Lohman ME, Vidal NY, Fought AJ, McGree ME, Keeney GL, Baum CL, Brewer JD, Bakkum-Gamez JN, Cliby WA. Mohs surgery for female genital Paget's disease: a prospective observational trial. Am J Obstet Gynecol. 2023 Dec;229(6):660.e1-660.e8. doi: 10.1016/j.ajog.2023.08.018. Epub 2023 Aug 24.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2018
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Pathological Conditions, Signs and Symptoms; Disease; Paget Disease, Extramammary
• Other Study ID Numbers: 17-007532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No