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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01545544
Other study ID # ANRS HC13 Lympho C
Secondary ID
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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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


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
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