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临床试验/NCT02877589
NCT02877589已完成不适用

Interest of Routine Screening for Hepatitis B and C in Patients Receiving Chemotherapy for Solid Tumors

CHU de Reims1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
450
试验地点
1
主要终点
hepatitis B virus (HBV) serological status

研究概览

简要总结

Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but can cause fulminant hepatitis and death. More, they impact the treatment of cancer by chemotherapy delays or stops. They can occur during cancer treatment but also after stopping, at the immunological rebound. This risk persists for at least 6 months after cessation.

The key to the prevention, and the first step, is serological testing. It is also the main problem because international recommendations diverge. Hepatologists and infectious disease specialists recommend routine screening HBV of all candidates for immunosuppressive therapy. These recommendations are more implemented by hematologists, given the frequency of HBV reactivation associated to haematological malignancies. Clinical oncology societies guidelines suggest a selective screening in case of risk factors of hepatitis B or in patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell transplantation or lymphoma treatment).

The consequence of these differences is a sub-screening by oncologists and the persistence of fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV and HCV can be assessed.

详细描述

The aims of the study were :

evaluate the seroprevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in patients receiving cytotoxic chemotherapy for solid tumors.

assess the relevance of screening questions to detect risk factors of hepatitis B virus (HBV) and hepatitis C virus (HCV) and to analyze the patients with superior risk of viral reactivation

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

  • patients receiving chemotherapy for solid tumors in Ambulatory Medicine Unit of the Reims University Hospital (France) between May 14, 2012 and July 31, 2013

排除标准

  • 未提供

结局指标

主要结局

hepatitis B virus (HBV) serological status

时间窗: Day 0

Serological status for hepatitis B virus (HBV) classified in "HBV exposed", "HBV vaccine" and "HBV negative"

次要结局

  • hepatitis C virus (HCV) serological status(Day 0)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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