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:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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: January 23, 2013
Last verified: March 2012
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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) |
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
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: | January 23, 2013 |
| 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 May 19, 2013