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

Solid Tumor Clinical Trial

— HepScreen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877589
• Other study ID #: 2015Ao002
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: August 23, 2016
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis B
• Solid Tumor

Intervention

Other:
• 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)

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Brasseur M, Heurgué-Berlot A, Barbe C, Brami C, Rey JB, Vella-Boucaud J, Dabouz F, Deslée G, Grange F, Volet J, Bouché 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hepatitis B virus (HBV) serological status	Serological status for hepatitis B virus (HBV) classified in "HBV exposed", "HBV vaccine" and "HBV negative"	Day 0	No
Secondary	hepatitis C virus (HCV) serological status	Serological status for hepatitis C virus (HBC) classified in "HBC positive" and "HBC negative"	Day 0	No