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

NCT ID: NCT02877589

Last Updated: 2016-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Solid Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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solid tumor

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

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)

Intervention Type OTHER

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Reims

Reims, France, France

Site Status

Countries

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France

References

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Brasseur M, Heurgue-Berlot A, Barbe C, Brami C, Rey JB, Vella-Boucaud J, Dabouz F, Deslee G, Grange F, Volet J, Bouche O. Prevalence of hepatitis B and C and sensibility of a selective screening questionnaire in patients receiving chemotherapy for solid tumors. BMC Cancer. 2015 Dec 23;15:999. doi: 10.1186/s12885-015-2033-z.

Reference Type BACKGROUND
PMID: 26694960 (View on PubMed)

Other Identifiers

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2015Ao002

Identifier Type: -

Identifier Source: org_study_id

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