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

Primary Purpose

Hodgkin's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood specimen
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hodgkin's Disease focused on measuring Hodgkin Lymphoma, Adult, Cytokines, TARC, IL-6, IL1-RA, sCD30, TNFR1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

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)

Outcomes

Primary Outcome Measures

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
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

Correlation between the decrease of cytokines plasma levels and event-free survival
Evaluation of correlation between the decrease of cytokines plasma levels and event-free survival after 3 years of follow-up

Full Information

First Posted
October 23, 2012
Last Updated
July 19, 2017
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT01833884
Brief Title
Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic
Acronym
CYTOKINES-LH
Official Title
Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease
Keywords
Hodgkin Lymphoma, Adult, Cytokines, TARC, IL-6, IL1-RA, sCD30, TNFR1

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Collection of blood specimen
Intervention Description
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 Measure Information:
Title
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
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
Time Frame
90 days after end of treatment
Secondary Outcome Measure Information:
Title
Correlation between the decrease of cytokines plasma levels and event-free survival
Description
Evaluation of correlation between the decrease of cytokines plasma levels and event-free survival after 3 years of follow-up
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aspasia STAMATOULLAS, MD
Organizational Affiliation
CENTRE HENRI BECQUEREL-Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Kinetic of Cytokines Decrease and Hodgkin Lymphoma Prognostic

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