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: January 23, 2013

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 21, 2012

Last Updated Date

January 23, 2013

Start Date ^ICMJE

November 2006

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01545544 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

whole blood and bone marrow

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

138

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01545544

Other Study ID Numbers ^ICMJE

ANRS HC13 Lympho C

Has Data Monitoring Committee

Yes

Responsible Party

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Sponsor ^ICMJE

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Olivier HERMINE, PU-PH	Hôpital Necker (Paris 15è), Service d'hématologie
Study Chair:	Fabrice CARRAT, PU-PH	Unité INSERM 707

Information Provided By

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Verification Date

March 2012

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

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