NCT01833884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

6.1 years

First QC Date

October 23, 2012

Last Update Submit

July 19, 2017

Conditions

Hodgkin's Disease

Keywords

Hodgkin Lymphoma, AdultCytokinesTARCIL-6IL1-RAsCD30TNFR1

Outcome Measures

Primary Outcomes (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

    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

    90 days after end of treatment

Secondary Outcomes (1)

  • Correlation between the decrease of cytokines plasma levels and event-free survival

    3 years

Study Arms (1)

Single arm

OTHER

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

Interventions

Collection of blood specimenOTHER

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)

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Aspasia STAMATOULLAS, MD

    CENTRE HENRI BECQUEREL-Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

April 17, 2013

Study Start

April 1, 2010

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)