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OpenTrials
Completed

NCT Number: NCT02877589

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Reims

Reims, France, 51092

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies and a screening questionnaire to detect risk factors of hepatitis B virus (HBV) and hepatitis C virus (HCV)

Other

Primary outcomes

  1. hepatitis B virus (HBV) serological status

    Time frame: Day 0

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

Secondary outcomes

  1. hepatitis C virus (HCV) serological status

    Time frame: Day 0

    Serological status for hepatitis C virus (HBC) classified in "HBC positive" and "HBC negative"

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: HepScreen

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Aug 24, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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