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Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment


N/A
18 Years
N/A
Open (Enrolling)
Both
Hodgkin's Disease

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Trial Information

Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment


To evaluate the decrease of cytokines concentration with a prognostic value as markers of
response, the dosage of TARC, IL-6, IL1-RA, sCD30 and TNFR1 will be performed during
treatment at :diagnosis, cycle 1 day 15, cycle 2 Day 1, cycle 3 Day 1, Day 1 of
consolidation (Cycle 5 day 1 or before radiotherapy) and evaluation of end of treatment.

an early follow-up with a dosage of cytokines will be performed 3 months after the end of
treatment.

An evaluation for Event Free Survival will be done at 3 years from diagnosis.


Inclusion Criteria:



- Hodgkin Lymphoma diagnosis

- I-II or III-IV Stages

- untreated Patient (including corticosteroids)

- Patient treated and followed exclusively in center Henri Becquerel

- Informed Consent signed

Exclusion Criteria:

- psychological, social or family conditions not allowing a suitable follow-up for
study

- Mental deficiency not allowing the good understanding of study procedures

- positive HIV serology

- positive B or C Hepatitis serology

- Pregnant or lactating

- Patient registered with a social security scheme or in an equivalent situation

- Patient in a period of exclusion on another biomedical study.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Decrease of cytokines concentration TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up in Hodgkin's disease

Outcome Description:

evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment (At Cycle 1 Day 15 of chemotherapy,Cycle 2 Day 1, cycle 3 Day 1, Cycle 5 Day 1 or Day 1 of Radiotherapy, 1 month after the end of treatment) , and during early follow-up (3 months after the end of treatment) in patients with Hodgkin's disease

Outcome Time Frame:

90 days after end of treatment

Safety Issue:

No

Principal Investigator

Aspasia STAMATOULLAS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CENTRE HENRI BECQUEREL-Rouen

Authority:

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

Study ID:

CHB 09-02

NCT ID:

NCT01833884

Start Date:

April 2010

Completion Date:

January 2016

Related Keywords:

  • Hodgkin's Disease
  • Hodgkin Lymphoma, Adult
  • Cytokines
  • TARC
  • IL-6
  • IL1-RA
  • sCD30
  • TNFR1
  • Hodgkin Disease
  • Lymphoma

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