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临床试验/NCT04099446
NCT04099446撤回不适用

A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma

ProgenaBiome1 个研究点 分布在 1 个国家开始时间: 2019年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing

研究概览

简要总结

This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.

详细描述

The human Skin microbiome is a complex, interconnected web of microbes, living in a symbiotic relationship with their host. There are greater than ten times more bacteria on our bodies than there are human cells, all in a delicate and ever-changing balance to maintain a healthy skin microbiome. When this balance is disrupted, a condition known as dysbiosis, disease can occur. There is still a debate over whether dysbiosis is a cause of disease or a symptom of it. Naturally, since the microbiome has such a profound impact on human health, we want to study and learn as much about the microbiome as possible. By correlating this data with medical records for the patient's skin cancer, connections may begin to be drawn between organisms present in the microbiome of the skin microbiome, and skin cancer. Much like fingerprints, no microbiome is identical therefore the only chance we have at understanding disease is by looking at the skin microbiome and comparing the microorganisms on a patient with skin cancer biopsy and non-skin cancer biopsy.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Signed informed consent
  • 18 years of age or older
  • Diagnosis of skin cancer, both melanoma and non-melanoma
  • Able/willing to have a skin punch biopsy in a non-cancerous location

排除标准

  • Unable/unwilling to sign informed consent
  • Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

结局指标

主要结局

Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing

时间窗: 1 year

Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the skin microbiome in both cancerous and non-cancerous areas. These data will then be compared to elucidate unique qualities of the microbiome in skin cancer.

次要结局

  • Validation of sequencing methods(1 year)

研究者

发起方
ProgenaBiome
申办方类型
Other
责任方
Sponsor

研究点 (1)

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