NCT03932279招募中不适用
Characterization of the Microbiome in Cutaneous T Cell Lymphoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Bacterial diversity index
研究概览
简要总结
Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma
- •Group 2: Patients with stage IIB and above cutaneous T cell lymphoma
- •Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma
- •Group 4: Patients with plaque psoriasis with BSA>5% on routine phototherapy per standard of care
- •Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care
- •Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma
- •All Groups: subjects who are age 18-89 years of age at time of enrollment
- •All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443).
排除标准
- •All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
- •All Groups: Subjects who are unable to give consent
- •Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics
- •We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
研究组 & 干预措施
Healthy controls
Stage IA-IIA cutaneous T cell lymphoma
CD30+ lymphoproliferative disorders
Plaque psoriasis with BSA>5% on routine phototherapy
Moderate to severe atopic dermatitis on routine bleach bath
Stage IIB and above cutaneous T cell lymphoma
结局指标
主要结局
Bacterial diversity index
时间窗: 3 months
Diversity analysis of microbiome samples (measured by number of bacteria species/sample)
次要结局
未报告次要终点
研究者
Xiaolong (Alan) Zhou
Principal Investigator
Northwestern University
研究点 (2)
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