Gynecologic Extramammary Paget's Disease | NCT03564483

Studies
Gynecologic Extramammary Paget's Disease

NCT03564483

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

100Estimated

Phase

Not provided

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)
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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2018Actual

Primary Completion Date

Dec 2050Estimated

Completion Date

Dec 2050Estimated

First Submitted Date

Jun 11, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

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)
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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Registry Observational Study		All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women diagnosed with Extramammary Paget's Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Jamie N. Bakkum-Gamez, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic	Recruiting	Rochester	Minnesota	55905	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37633576	Derived	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.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018299	Neoplasms, Ductal, Lobular, and Medullary
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010145	Paget Disease, Extramammary
D004194	Disease