Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
研究概览
简要总结
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
详细描述
The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households
排除标准
- •Age under 18 years
- •Pregnancy
- •Substance abuse
- •Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
- •Chronic gastrointestinal disorder
- •Gastrointestinal surgeries in the past 2 years
- •Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)
研究组 & 干预措施
MULTIPLE MYELOMA at diagnosis GROUP
Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant
干预措施: Non-interventional study (observational) (Other)
Amyloid at diagnosis GROUP
AL amyloidosis (before starting chemotherapy or stem cell transplant)
干预措施: Non-interventional study (observational) (Other)
Poems at diagnosis GROUP
POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant
干预措施: Non-interventional study (observational) (Other)
Poems in Remission GROUP
POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years
干预措施: Non-interventional study (observational) (Other)
MGUS GROUP
MGUS -not treated newly diagnosed
干预措施: Non-interventional study (observational) (Other)
Health controls in same household GROUP
household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate)
干预措施: Non-interventional study (observational) (Other)
结局指标
主要结局
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
时间窗: Baseline
Stool samples will be collected by the patient using a stool self- collection kit provided to the participant by the study staff. Samples will be evaluated for characteristics of gut microbiome (α-diversity and β-diversity).
次要结局
未报告次要终点