Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Jamie N. Bakkum-Gamez, M.D.
PRINCIPAL_INVESTIGATOR
Karen P Ishitani, RN
CONTACT
Maureen A. Lemens, R.N.
CONTACT
NCT Number: NCT03564483
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Jamie N. Bakkum-Gamez, M.D.
PRINCIPAL_INVESTIGATOR
Karen P Ishitani, RN
CONTACT
Maureen A. Lemens, R.N.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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..
Contact information is provided by the study sponsor or research team.
Karen P Ishitani, RN
CONTACT
Maureen A. Lemens, R.N.
CONTACT
Mayo Clinic
Other
Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06873815
Adenocarcinoma, Carcinoma
Basking Ridge, New Jersey, United States
View Trial DetailsNCT01526486
Adenocarcinoma, Anal Cancer
Atlanta, Georgia, United States
View Trial DetailsNCT03713203
Adenocarcinoma, Carcinoma
Lille, France
View Trial DetailsNCT05859074
Adenocarcinoma, Adenocarcinoma, Sebaceous
Basking Ridge, New Jersey, United States
View Trial Details