Extramammary Paget's DiseaseNCT03564483
Gynecologic Extramammary Paget's Disease
An observational study of Extramammary Paget's Disease and Extramammary Paget Disease, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Extramammary Paget's Disease, Extramammary Paget Disease, Paget Disease, Extramammary
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with Extramammary Paget's Disease
Who may be able to join
- 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
Who cannot join
- Males
- Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Maureen A. Lemens, R.N., 507-293-1487, lemens.maureen@mayo.edu
Karen P Ishitani, RN, 507-538-5355, ishitani.karen@mayo.edu
About this study
Official title: 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.
Read the 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
- 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
- Medical subject headings
- Paget Disease, Extramammary, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Registry Observational Study | All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start19 Feb 2018
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extramammary Paget's DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie N. Bakkum-Gamez, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564483
- Sponsor's protocol ID
- 17-007532
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2018
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37633576
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
- ClinicalTrials.gov ID
- NCT03564483
- Acronym / sponsor ID
- 17-007532
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry Observational Study | – | –All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with Extramammary Paget's Disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Males
- Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).
Time frame: 25 years
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..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 37633576Bruce 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamie N. Bakkum-Gamez, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extramammary Paget's Disease and Extramammary Paget Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen A. Lemens, R.N. (507-293-1487, lemens.maureen@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD). (time frame: 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.