Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)

NCT01545544 | Unknown DMC

• 1 other identifier: ANRS HC13 Lympho C
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Conditions

Chronic Hepatitis C

Keywords

B-Cell Non Hodgkin Lymphomas; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• presentation of NHL and HCV infection, and treatments of NHL and HCV infection

  the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics

  at the first visit (Day 0)

Secondary Outcomes (3)

• Summary of intercurrents biological and clinical events

  Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60

• virological response

  Month 60

• haematological response

  Month 60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with HCV infection with positive viral load and a B-cell NHL.

You may qualify if:

• Patients with evolving NHL whatever its histological type
• At diagnosis or relapse or failure previous treatments stopped over 3 months
• Patients with HCV infection with positive quantitative viral load
• years or more of age
• Life expectancy greater than 6 months
• Signed and informed consent
• Benefit from social security

You may not qualify if:

• Active uncontrolled infection (out hepatitis C)
• HIV (Human immunodeficiency virus) infection
• Severe psychiatric history

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Hôpital Necker

Paris, France

Location

Related Publications (1)

• Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Beral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.

  PMID: 25417909 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and bone marrow

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier HERMINE, PU-PH

  Hôpital Necker (Paris 15è), Service d'hématologie

  PRINCIPAL INVESTIGATOR

• Fabrice CARRAT, PU-PH

  Unité INSERM 707

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 6, 2012
• Study Start: November 1, 2006
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: February 7, 2014

Record last verified: 2013-06

Locations

FR (1)