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

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ClinicalTrials.gov Identifier: NCT01545544
Recruitment Status : Unknown
Verified June 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Active, not recruiting
First Posted : March 6, 2012
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Chronic Hepatitis C

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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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.


Study Design

Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Case-Only
Official Title: Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
Study Start Date : November 2006
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. presentation of NHL and HCV infection, and treatments of NHL and HCV infection [ Time Frame: at the first visit (Day 0) ]
    the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics


Secondary Outcome Measures :
  1. Summary of intercurrents biological and clinical events [ Time Frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60 ]
  2. virological response [ Time Frame: Month 60 ]
    HCV quantitative viral load

  3. haematological response [ Time Frame: Month 60 ]
    to evaluate the correlation between hematological and virological response


Biospecimen Retention:   Samples With DNA
whole blood and bone marrow

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: June 2013

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