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Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer (PROFILER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Leon Berard
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01774409
First received: January 16, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a retrospective clinical data collection and with a genetic and immunologic biomarkers study.

The ProfiLER program aims to implement a personalized cancer medicine approach by proposing to establish the genetic and immunologic profile of the tumor for patients with an advanced malignant tumor, in order to define a map of genetic (for the pre-identified target genes) and immunologic profiles for all the studied types of cancer. This study will also allow adapting the therapeutic management of these patients, if needed, by giving them targeted therapies or immunotherapies (commercialized on in ongoing clinical trials), based on the recommendations of the multidisciplinary molecular board.

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected (biopsy of a reachable lesion) tumor sample and from a blood sample. The correlation between genetic profiles of the tumor, patients immunity status and retrospective clinical data (progression, tumor response, etc.) collected from the patient medical records will probably allow us to identify biomarkers with a potential predictive value and to determine if some genetic disorders are linked to immunity status alterations.


Condition Intervention
Neoplasms
Genetic: Blood and tumor samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors. [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]
    Description of the incidence rates of each detected genetic disorder among the pre-identified target genes in the global cohort and for each histological type.


Secondary Outcome Measures:
  • Establish a map of immunologic profiles for all types of advanced malignant tumors. [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]
    Description of the incidence rates of each detected immunologic disorder in the global cohort and for each histological type.

  • Determine for each histological type of tumor, characteristic profiles of genetic and/or immunologic disorders and disorders that might be common to several histological types. [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]
    Comparison of the genetic and immunologic profiles between patients with the same tumor type or between tumors of different types.

  • Identify genetic and/or immunologic biomarkers (or molecular profiles) with a potential predictive value on response to treatments. [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]
    Tumor response (determined by the investigator and/or the radiologist) assessed after each treatment received by the patient during his/her whole participation to the study (if data are available in the medical record).

  • Identify biomarkers (constitutional or somatic alterations in tumor cells) that might be correlated with systemic or local alterations of the immunity status observed in some patients with advanced cancers [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]
    lymphopenia, over-representation of Treg, dendritic cells alterations,

  • Assess the changes of genetic and/or immunologic profiles in case of progressive disease [ Time Frame: 3 years after first patient enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: February 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood and tumor samples Genetic: Blood and tumor samples

Genetic: Establishment of the genetic and immunologic profile

Whole blood sampling :

  • 1 tube for the constitutional DNA extraction;
  • 3 tubes for ancillary studies and research.

Collection of the available archival tumor sample (frozen or FFPE). If there's no available sample, the investigator will prescribe a biopsy of a reachable lesion.

With the established profile, recommendations will be given by a multidisciplinary molecular board.


Detailed Description:

Determination of the tumor profile and review in multidisciplinary molecular board:

The genetic and immunologic profile will be performed from the available tumor sample and from a blood sample.

Genetic profile:

  • Research of mutations/insertions/deletions for an array of predefined genes in tumor deoxyribonucleic acid by high-throughput sequencing
  • Analysis of copy number variations of genes on tumor deoxyribonucleic acid by microarray-based comparative genomic hybridization
  • Analysis of rearrangements involving the gene Anaplastic Lymphoma Kinase that can't be detected by Next Generation Sequencing or array Comparative Genomic Hybridization (balanced translocations) by means of fluorescent hybridization probes on tumor samples Immunologic profile: analysis of the expression of relevant immunologic markers

Retrospective clinical data collection:

Patients' clinical data will be collected retrospectively from the patient medical record. This study is not a treatment evaluation. Patients' follow-up and treatment will be performed according to the center local practices or to the specificities of a clinical trial in which the patient would have been enrolled, depending on the recommendations given by the multidisciplinary molecular board, with the review of the tumor genetic profile.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced (locally-advanced or metastatic) malignant tumor of any histological type
  • Tumor sample available to determine the genetic profile: either archival tumor sample [FFPE (formalin fixed and paraffin embedded)] or perform a new biopsy on an accessible lesion (left at the investigator's appreciation). Please note that brain and bone lesions are not considered as accessible lesions.
  • Patient must be covered by a medical insurance.
  • Informed consent signed by the patient and/or by parents (or legal representative) for patients below 18.

Exclusion Criteria:

  • No tumor sample available.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774409

Contacts
Contact: Jean-Yves BLAY, MD +33 4 78 78 51 26 jean-yves.blay@lyon.unicancer.fr

Locations
France
Centre Léon Bérard Recruiting
Lyon, France, 69008
Sub-Investigator: Thomas BACHELOT, MD         
Sub-Investigator: Amine BELHABRI, MD         
Sub-Investigator: Christophe BERGERON, MD         
Sub-Investigator: Pierre BIRON, MD         
Sub-Investigator: Helen BOYLE, MD         
Sub-Investigator: Philippe CASSIER, MD         
Sub-Investigator: Patrick COMBEMALE, MD         
Sub-Investigator: Françoise DESSEIGNE, MD         
Sub-Investigator: Cécile FAURE-CONTER, MD         
Sub-Investigator: Jérome FAYETTE, MD         
Sub-Investigator: Aude FLECHON, MD         
Sub-Investigator: Christelle DE LA FOUCHARDIERE, MD         
Sub-Investigator: Didier FRAPPAZ, MD         
Sub-Investigator: Hervé GHESQUIERES, MD         
Sub-Investigator: Jean-Paul GUASTALLA, MD         
Sub-Investigator: Pierre GUIBERT, MD         
Sub-Investigator: Pierre-Etienne HEUDEL, MD         
Sub-Investigator: Aurélien MARABELLE, MD         
Sub-Investigator: Sylvie NEGRIER, MD         
Sub-Investigator: Eve-Marie NEIDHARDT, MD         
Sub-Investigator: Emmanuelle NICOLAS-VIRELIZIER, MD         
Sub-Investigator: Maurice PEROL, MD         
Sub-Investigator: Isabelle RAY-COQUARD, MD         
Sub-Investigator: Paul REBATTU, MD         
Sub-Investigator: Catherine SEBBAN, MD         
Sub-Investigator: Olivier TREDAN, MD         
Sub-Investigator: Alice LEVARD, MD         
Sub-Investigator: Virginie AVRILLON, MD         
Sub-Investigator: Louis TASSY, MD         
Hôpital Edouard Herriot Not yet recruiting
Lyon, France, 69003
Principal Investigator: Julien FORESTIER, MD         
Sub-Investigator: Catherine LOMBARD BOHAS, MD         
Sub-Investigator: Thomas WALTER, MD         
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre-Bénite Cedex, France, 69495
Principal Investigator: Benoît YOU, MD         
Sub-Investigator: Cécile FOURNEL-FEDERICO, MD         
Sub-Investigator: Gilles FREYER, MD         
Sub-Investigator: Sophie TARTAS, MD         
Sub-Investigator: Véronique TRILLET-LENOIR, MD         
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Jean-Yves BLAY, MD PhD Centre Léon Bérard
  More Information

Publications:
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01774409     History of Changes
Other Study ID Numbers: PROFILER, ET12-082
Study First Received: January 16, 2013
Last Updated: March 13, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Leon Berard:
all advanced malignant tumor

ClinicalTrials.gov processed this record on November 20, 2014