Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT03564483

Conditions

Extramammary Paget's Disease

Extramammary Paget Disease

Paget Disease, Extramammary

Extramammary Paget's Disease of Vulva (Diagnosis)

Extramammary Paget's Disease of Vagina (Diagnosis)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Extramammary Paget Disease

Paget Disease, Extramammary

Extramammary Paget's Disease of Vulva (Diagnosis)

Extramammary Paget's Disease of Vagina (Diagnosis)

Study ID

NCT03564483

Start date

Feb 19, 2018

Status verified date

Jan, 2026

Completion date

Dec, 2050

Anticipated

Primary completion date

Dec, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Observational Study

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

Primary outcome measure

  • Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD). [ Time Frame: 25 years ]

Central Contacts and Locations

Central contacts

Maureen A. Lemens, R.N.

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

Karen P Ishitani, RN

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Maureen A. Lemens, R.N.

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

Karen P Ishitani, RN

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

Principal Investigator:

Jamie N. Bakkum-Gamez, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-28.