Gynecologic Extramammary Paget's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03564483|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
|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|
|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|
|Registry Observational Study|
- 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.
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
|Contact: Maureen A. Lemens, R.N.||firstname.lastname@example.org|
|Contact: Toni Kilts, D.O.||email@example.com|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Maureen A. Lemens, R.N. 507-293-1487 firstname.lastname@example.org|
|Contact: Toni Kilts, D.O. email@example.com|
|Principal Investigator: Jamie N. Bakkum-Gamez, M.D.|
|Principal Investigator:||Jamie N. Bakkum-Gamez, M.D.||Mayo Clinic|