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


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Hepatitis C

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Trial Information

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


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follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only

Outcome Measure:

presentation of NHL and HCV infection, and treatments of NHL and HCV infection

Outcome Description:

the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics

Outcome Time Frame:

at the first visit (Day 0)

Safety Issue:

No

Principal Investigator

Olivier HERMINE, PU-PH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Necker (Paris 15è), Service d'hématologie

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ANRS HC13 Lympho C

NCT ID:

NCT01545544

Start Date:

November 2006

Completion Date:

November 2014

Related Keywords:

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

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