Assessment of Blood Biomarkers by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans

NCT01287923 | Completed

• 3 other identifiers: 2010-A00812-37TRANS/10-01B101038-10
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 17

Brief Summary

Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.

Conditions

DLBCL

Keywords

Hematology; Secondary lymphoid organs

Outcome Measures

Primary Outcomes (1)

• Research for cancer-related biomarkers

  In this project we propose two complementary approaches with a first one orientated to the continuum of our current findings based on genes differentially expressed in blood between DLBCL patients and healthy people and a second one which takes in account the power and originality of our 075 GOELAMS cohort and will be focused on the research of predictive signatures of the DLBCL. We will go beyond the sole transcriptomic approach and also look for relevant cell biology clues.

  3 years

Secondary Outcomes (4)

• Sensitivity & specificity of the identified molecular signature in the DLBCL diagnosis context

  3 years

• Identify a prognostic whole blood RNA signature related to aggressive DLBCL

  3 years

• Proportion and phenotypic characteristics of circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL

  3 years

• Immune functions of these circulating cells expressing the previously identified biomarkers at the time of diagnosis of DLBCL

  3 years

Study Arms (4)

DLBCL

DLBCL patients included 075-GOELAMS trial or 075-like patient.

Healthy controls

Blood donors from the EFS (French Blood Bank) of Rennes.

Septic patients

septic patients included at the Rennes University Hospital.

DLBCL in completed remission

DLBCL patients from the 075 GOELAMS study in completed remission.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

DLBCL or Healthy blood donors or septic patient or GOELAMS 075 patients in completed remission

You may qualify if:

• DLBCL or Healthy blood donors or septic patient or GOELAMS 075 patients in completed remission
• Written informed consent

You may not qualify if:

• Age \< 18 or \> 70
• Not written informed consent
• Not affiliated with social security

Sponsors & Collaborators

• Rennes University Hospital: lead
• French Innovative Leukemia Organisation: collaborator
• National Cancer Institute, France: collaborator

Study Sites (17)

Amiens University Hospital

Amiens, 80054, France

Location

Angers University Hospital

Angers, MD, France

Location

Victor Dupouy Hospital

Argenteuil, 95100, France

Location

Cesson-Sévigné Clinic

Cesson-Sévigné, 35576, France

Location

La Roche-sur-Yon Hospital

La Roche-sur-Yon, 85025, France

Location

Lille University Hospital

Lille, 59037, France

Location

Lorient Hospital

Lorient, 56100, France

Location

Nantes University Hospital (Hôtel-Dieu)

Nantes, 44093, France

Location

Bordeaux University Hospital ( Haut-Lévêque Hospital)

Pessac, 33604, France

Location

Poitiers University Hospital

Poitiers, MD, France

Location

Rennes EFS

Rennes, 35000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Saint-Brieuc Hospital

Saint-Brieuc, 22000, France

Location

Loire Cancer Institute

Saint-Priest-en-Jarez, 42271, France

Location

Saint-Malo Hospital

St-Malo, 35400, France

Location

Toulouse University Hospital

Toulouse, 35059, France

Location

Vannes Hospital

Vannes, 56000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

For this study, 4 newly included cohorts are necesseray : * 100 new DLBCL patients are necessary. The blood will be taken at the diagnosis for DLBCL patients included 075-GOELAMS trial or 075-like patient. * 100 healthy blood donors. This cohort of matched for sex \& gender will be constituted at the EFS (French Blood Bank) of Rennes. * 100 septic patients included at the Rennes University Hospital. * 100 075-like DLBCL patients in completed remission. This project will also used already available blood collections: 2) Mantle cell lymphoma, 3) localized DLBCL and septic shock. Paraffin blocks of patient 075-trial DLBCLs are in the GOELAMSthèque bank localized in the Pathology Department Hôtel Dieu, Paris supervised by Pr Diane Damotte. Tissue Microarrays and complete paraffin blocks as well as some -80° tumors are already available.

Study Officials

• Thierry Fest, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 2, 2011
• Study Start: February 21, 2011
• Primary Completion: June 8, 2017
• Study Completion: September 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

FR (17)