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Gynecologic Extramammary Paget's Disease

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ClinicalTrials.gov Identifier: NCT03564483
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie N. Bakkum-Gamez, Mayo Clinic

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.

Condition or disease
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

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Group/Cohort
Registry Observational Study



Primary Outcome Measures :
  1. 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..


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women diagnosed with Extramammary Paget's Disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564483


Contacts
Contact: Maureen A. Lemens, R.N. 507-293-1487 lemens.maureen@mayo.edu
Contact: Toni Kilts, D.O. kilts.toni@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Maureen A. Lemens, R.N.    507-293-1487    lemens.maureen@mayo.edu   
Contact: Toni Kilts, D.O.       kilts.toni@mayo.edu   
Principal Investigator: Jamie N. Bakkum-Gamez, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jamie N. Bakkum-Gamez, M.D. Mayo Clinic

Responsible Party: Jamie N. Bakkum-Gamez, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03564483     History of Changes
Other Study ID Numbers: 17-007532
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Paget Disease, Extramammary
Skin Diseases
Vulvar Diseases
Vaginal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary
Genital Diseases, Female