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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01545544
First received: February 21, 2012
Last updated: February 6, 2014
Last verified: June 2013
  Purpose

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.


Condition
Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • presentation of NHL and HCV infection, and treatments of NHL and HCV infection [ Time Frame: at the first visit (Day 0) ] [ Designated as safety issue: No ]
    the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics


Secondary Outcome Measures:
  • Summary of intercurrents biological and clinical events [ Time Frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60 ] [ Designated as safety issue: Yes ]
  • virological response [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    HCV quantitative viral load

  • haematological response [ Time Frame: Month 60 ] [ Designated as safety issue: No ]
    to evaluate the correlation between hematological and virological response


Biospecimen Retention:   Samples With DNA

whole blood and bone marrow


Enrollment: 138
Study Start Date: November 2006
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Main objectives are:

  • Description of the clinical and histological characteristics, treatment and evolution of these NHL.
  • Study their physiopathology by immunological, virologic and molecular studies.

The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.

The enrolment period is 6 years and the total study lasts 8 years.

  • "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
  • "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.

The enrollment is estimated at 140 patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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
  • 18 years or more of age
  • Life expectancy greater than 6 months
  • Signed and informed consent
  • Benefit from social security

Exclusion Criteria:

  • Active uncontrolled infection (out hepatitis C)
  • HIV (Human immunodeficiency virus) infection
  • Severe psychiatric history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545544

Locations
France
Hôpital Necker
Paris, France
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
Principal Investigator: Olivier HERMINE, PU-PH Hôpital Necker (Paris 15è), Service d'hématologie
Study Chair: Fabrice CARRAT, PU-PH Unité INSERM 707
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01545544     History of Changes
Other Study ID Numbers: ANRS HC13 Lympho C
Study First Received: February 21, 2012
Last Updated: February 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
B-Cell Non Hodgkin Lymphomas
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014