Prospective Registry of Gynecologic Patients With Extramammary Paget's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of Paget's Disease in body areas other than vulvar or perianal region
研究组 & 干预措施
Registry Observational Study
All women presenting for evaluation of Extramammary Paget's Disease (EMPD) at Mayo Clinic in Rochester MN.
结局指标
主要结局
Collect prospective data including outcomes and long-term survival in women with extramammary Paget's disease (EMPD).
时间窗: 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..
次要结局
未报告次要终点