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

February 21, 2012
February 6, 2014
November 2006
November 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01545544 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus

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.

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.

Observational
Observational Model: Case-Only
Not Provided
Retention:   Samples With DNA
Description:

whole blood and bone marrow

Non-Probability Sample

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

Chronic Hepatitis C
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01545544
ANRS HC13 Lympho C
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Olivier HERMINE, PU-PH Hôpital Necker (Paris 15è), Service d'hématologie
Study Chair: Fabrice CARRAT, PU-PH Unité INSERM 707
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP