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临床试验/NCT03932279
NCT03932279
招募中
不适用

Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Northwestern University2 个研究点 分布在 1 个国家目标入组 300 人2019年1月30日

概览

阶段
不适用
干预措施
Healthy controls
疾病 / 适应症
Cutaneous T Cell Lymphoma
发起方
Northwestern University
入组人数
300
试验地点
2
主要终点
Bacterial diversity index
状态
招募中
最后更新
昨天

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.

注册库
clinicaltrials.gov
开始日期
2019年1月30日
结束日期
2028年8月31日
最后更新
昨天
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Xiaolong (Alan) Zhou

Principal Investigator

Northwestern University

入排标准

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)

研究点 (2)

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