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临床试验/NCT03941158
NCT03941158已完成不适用

Cohabitation Patterns and Incidence of Known and Suspected Sexually Transmitted Diseases

Aarhus University Hospital0 个研究点目标入组 5,000,000 人开始时间: 2019年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000,000
主要终点
HIV, syphilis, and gonorrhea

研究概览

简要总结

The number of infectious agents associated with risks of malignant hematologic diseases is non-negligible and include both viruses and bacteria.

The various organisms affect cancer risk either directly by transforming susceptible cells, through chronic antigenic stimulation or by hampering immune function in other ways conducive of cancer development.

Suspicion of an infectious cancer origin may arise because of clustering with other conditions (e.g. immune deficiency), specific environments or settings (e.g. geographic locales) or with exposures (e.g. blood transfusions).

In this context, relatively few studies have addressed clustering of diseases among spouses to generate hypotheses about the relative contributions of environmental and genetic factors to the risk of individual cancer types.

As a prelude to such an exercise aiming specifically at malignant hematologic diseases, we will test an algorithm characterising cohabitation patterns in the Danish population to assess the risk of sexually transmitted diseases in analyses of register data.

Such information will also be relevant to current guidelines for blood donor deferral policies. Specifically, because of the so-called precautionary principle all blood donations are extensively tested for infectious agents and transfusion of blood now carries an extremely low risk of transmission of HIV, hepatitis B and C. The residual risk of HIV transmission in Denmark is estimated to 1:10,000,000 transfusions. However, several deferral criteria have existed for years without studies to prove their relevance.

Aim: To compare the incidence of both known and suspected sexually transmitted diseases between different cohabitation patterns in the Danish population.

Perspectives: The study results can be used to leverage changes in deferral rules in the Danish blood banks to accommodate strong wishes from stakeholders to avoid the perceived discrimination of various minorities. The study can thus have important ethical and political consequences.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • All citizens in Denmark

排除标准

  • Institutionalized individuals

结局指标

主要结局

HIV, syphilis, and gonorrhea

时间窗: 2005 - 2018

HIV, syphilis, and gonorrhea will be identified by registration in the Mandatory disease notification system administrated by Statens Serums Institut (SSI), Denmark.

Sexually transmitted diseases

时间窗: 1977 - 2018

The diseases will be identified by using the Danish National Patient Register (NPR). Diagnostic information is based on the International Classification of Diseases, Eight and Tenth Revision (ICD-8 and ICD-10).

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Erikstrup

Professor, Chief Physician

Aarhus University Hospital

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