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临床试验/NCT03709862
NCT03709862已完成不适用

Whole Genome Sequencing of Syphilis Using Routine Clinical Samples

London School of Hygiene and Tropical Medicine5 个研究点 分布在 1 个国家目标入组 726 人开始时间: 2018年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
726
试验地点
5
主要终点
Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage

研究概览

简要总结

Syphilis is an important sexually transmitted infection. There has been an epidemic of syphilis amongst men who have sex with men in the United Kingdom in the last decade. Early infection with syphilis causes a genital ulcer followed, in the absence of treatment, by a generalised illness often accompanied by rash. Studies on syphilis have been limited because it is not possible to grow syphilis outside of the body. New approaches allow the whole genetic sequence of Treponema pallidum to be obtained from a swab.

In this study residual DNA collected as part of routine patient care of patients seen at sexual health clinics in the UK will be used for sequencing. No patient contact is involved in the study which is limited to whole genome sequencing using residual material from samples. By better understanding the genome of the T.pallidum insights will be gained in to the pathogenesis of this important sexually transmitted disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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

  • Diagnosis of syphilis

排除标准

  • No PCR positive clinical sample

结局指标

主要结局

Genomic Diversity of Treponema Pallidum as assessed by nucleotide diversity and phylogenetic lineage

时间窗: Measured at baseline - time of enrollment. There are no further samples or visits in the study.

Whole genome sequencing of UK and global syphilis samples combined with phylogenomic and population genomic analyses to determine the population structure and diversity of Treponema both regionally and in global context. Diversity will be assessed by measuring nucleotide diversity between samples and reference genomes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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