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

Chronic Hepatitis C Clinical Trial

— Lympho C  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01545544
• Other study ID #: ANRS HC13 Lympho C
• Status: Active, not recruiting
• Phase: N/A
• First received: February 21, 2012
• Last updated: February 6, 2014
• Start date: November 2006
• Est. completion date: November 2014

Study information

• Verified date: June 2013
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
France	Hôpital Necker	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presentation of NHL and HCV infection, and treatments of NHL and HCV infection	the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics	at the first visit (Day 0)	No
Secondary	Summary of intercurrents biological and clinical events		Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60	Yes
Secondary	virological response	HCV quantitative viral load	Month 60	No
Secondary	haematological response	to evaluate the correlation between hematological and virological response	Month 60	No

External Links

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