Registry for Adults With Plasma Cell Disorders (PCD's)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Completion of baseline and longitudinal assessments in PCD patients
研究概览
简要总结
The primary purpose of this protocol is to create a registry of patients with plasma cell disorders (PCDs), including for example the cancer multiple myeloma (MM), who complete the assessment, previously known as a "geriatric assessment," as is outlined in this protocol. Secondary objectives include measuring the response rate to participation of patients in this study, assessing patient satisfaction with the questionnaire, and gathering information that would lend support for future research into these types of assessments in patients with PCDs. Additionally the study offers an optional blood draw to look at a genetic marker of aging called p16INK4a (IRB 15-1899, IRB 15-0244).
详细描述
OBJECTIVES:
Primary
- To create a Registry (to be called the PCD Registry) of PCD patients
- To have participating patients complete an assessment at enrollment and to repeat the assessment longitudinally over time.
Secondary
- To gather information, including patterns of patient care, that would lend support for future research in the PCD population. Specific research questions would be explored within separate IRB-reviewed protocols.
- To bank blood samples for future research involving adults with PCD's, specifically examining p16INK4a and other markers to be specified in future, separate, IRB-approved protocols as specific research questions are identified.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have an outpatient appointment or are hospitalized inpatient at UNC Cancer Hospitals, or affiliated clinic settings or participating sites for the evaluation and management of a PCD.
- •Patients have a documented diagnosis of PCD defined as the presence of a monoclonal protein and/or monoclonal plasma cell population. Examples of PCDs include but are not limited to monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple (active) myeloma; plasma cell leukemia; Castleman's disease; amyloidosis; light and/or heavy chain deposition disease; Polyneuropathy, Organomegaly, Endocrinopathy,Monoclonal gammopathy and Skin changes (POEMS) syndrome; and cryoglobulinemia.
- •Age ≥18 years.
- •Must consent to participation in this study and agree to complete the assessment at baseline and follow-up time points.
- •Must be able to read and speak English.
排除标准
- •Physical or psychiatric/behavioral illnesses or problems that the treating clinician feels would preclude successful participation in the study.
- •There are no imaging or lab studies required to determine eligibility.
结局指标
主要结局
Completion of baseline and longitudinal assessments in PCD patients
时间窗: 10 years
Creation of a Registry of Plasma Cell Disorder (PCD) patients
时间窗: 10 years
次要结局
- Response rates of assessment in PCD patients and their satisfaction with the assessment(10 years)
- Creation of information that would lend support for future PCD research(10 years)