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Trial record 3 of 1369 for:    Hodgkin

Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic (CYTOKINES-LH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01833884
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Brief Summary:

More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless, some patients relapse and others are resistant to any treatment. These patients represent 2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International Prognostic Score) cannot always detect patients at risk.

New prognostic factors are required to screen out these high risk patients. Among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment.

Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team published the prognostic value of the decrease of TARC (CC Thymus and Activation-related chemokine).

In daily practice, the early assessment of response by PET CT-scan is now an undeniable prognostic factor. Early identification of no-response or relapse is, in fact, based on clinical and imaging (PET-CT scan).

We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up. The dosage of these cytokines will be paired with radiological assessments.

A correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards.


Condition or disease Intervention/treatment Phase
Hodgkin's Disease Other: Collection of blood specimen Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment
Study Start Date : April 2010
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single arm
Collection of blood specimen for Cytokines dosing scheduled before, during and after treatment of Hodgkin's lymphoma (last collection date about 90 days after the end of treatment)
Other: Collection of blood specimen
Collection of blood specimen for Cytokines dosing scheduled before , during and after treatment of Hodgkin's lymphoma (last collection date about 90 days after the end of treatment)




Primary Outcome Measures :
  1. 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 [ Time Frame: 90 days after end of treatment ]
    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


Secondary Outcome Measures :
  1. Correlation between the decrease of cytokines plasma levels and event-free survival [ Time Frame: 3 years ]
    Evaluation of correlation between the decrease of cytokines plasma levels and event-free survival after 3 years of follow-up



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833884


Locations
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France
Centre Henri Becquerel
Rouen, France, 76000
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Aspasia STAMATOULLAS, MD CENTRE HENRI BECQUEREL-Rouen

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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT01833884    
Other Study ID Numbers: CHB 09-02
RCB : 2009-A01117-50 ( Other Identifier: AFSSAPS )
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Henri Becquerel:
Hodgkin Lymphoma, Adult
Cytokines
TARC
IL-6
IL1-RA
sCD30
TNFR1
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases