Gynecologic Extramammary Paget's Disease

NCT03564483 | Recruiting

• 1 other identifier: 17-007532
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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; Extramammary Paget Disease; Paget Disease, Extramammary; Extramammary Paget's Disease of Vulva (Diagnosis); Extramammary Paget's Disease of Vagina (Diagnosis); Extramammary Paget's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Registry Observational Study

All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with Extramammary Paget's Disease

You may qualify if:

• 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

You may not qualify if:

• Males
• Diagnosis of Paget's Disease in body areas other than vulvar or perianal region

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37633576 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissues will be obtained in order to perform tumor molecular profiling to identify targetable somatic mutations in EMPD. The vulvar and perianal microbiome of women with extramammary Paget's disease will be evaluated.

MeSH Terms

Conditions

Paget Disease, Extramammary; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jamie N. Bakkum-Gamez, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen A. Lemens, R.N.

CONTACT

507-293-1487; lemens.maureen@mayo.edu

Karen P Ishitani, RN

CONTACT

507-538-5355; ishitani.karen@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 20, 2018
• Study Start: February 19, 2018
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)