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

March 1, 2024 updated by: Centre Leon Berard

It is a non-randomized, multicentric, cohort study, combined with a biological sample collection, a 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Clinical data collection:

Patients' clinical data will be collected 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.

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Annecy, France, 74370
        • Recruiting
        • Centre Hospitalier Annecy Genevois
        • Principal Investigator:
          • Mélodie Carbonnaux, MD
        • Sub-Investigator:
          • Mathieu Baconnier, MD
        • Sub-Investigator:
          • Marie Louvel, MD
        • Sub-Investigator:
          • Emmanuel Maillard, MD
        • Sub-Investigator:
          • Aude Montchaud, MD
        • Sub-Investigator:
          • Oana Pop, MD
        • Sub-Investigator:
          • Laurence Renaud, MD
        • Sub-Investigator:
          • Sarah Sannicolo, MD
        • Sub-Investigator:
          • Laetitia Stefani, MD
        • Sub-Investigator:
          • Elsa Thimonier, MD
        • Sub-Investigator:
          • Marie Valee, MD
      • Grenoble, France, 38028
        • Recruiting
        • Groupement Hospitalier Mutualiste
        • Principal Investigator:
          • Cécile LEYRONNAS, MD
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Sub-Investigator:
          • Virginie AVRILLON, MD
        • Sub-Investigator:
          • Jérome FAYETTE, MD
        • Sub-Investigator:
          • Amine BELHABRI, MD
        • Sub-Investigator:
          • Christophe BERGERON, MD
        • Sub-Investigator:
          • Pierre BIRON, MD
        • Sub-Investigator:
          • Helen BOYLE, MD
        • Sub-Investigator:
          • Patrick COMBEMALE, MD
        • Sub-Investigator:
          • Françoise DESSEIGNE, MD
        • Sub-Investigator:
          • Cécile FAURE-CONTER, MD
        • Sub-Investigator:
          • Aude FLECHON, MD
        • Sub-Investigator:
          • Christelle DE LA FOUCHARDIERE, MD
        • Sub-Investigator:
          • Jean-Paul GUASTALLA, MD
        • Sub-Investigator:
          • Pierre GUIBERT, 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:
          • Paul REBATTU, MD
        • Sub-Investigator:
          • Catherine SEBBAN, MD
        • Sub-Investigator:
          • Alice LEVARD, MD
        • Sub-Investigator:
          • Louis TASSY, MD
        • Sub-Investigator:
          • Isabelle RAY-COQUARD, MD
        • Sub-Investigator:
          • Philippe CASSIER, MD
        • Sub-Investigator:
          • Olivier TREDAN, MD
        • Sub-Investigator:
          • Thomas BACHELOT, MD
        • Sub-Investigator:
          • Hervé GHESQUIERES, MD
        • Sub-Investigator:
          • Pierre-Etienne HEUDEL, MD
      • Lyon, France, 69003
        • Not yet recruiting
        • Hopital Edouard Herriot
        • Principal Investigator:
          • Julien FORESTIER, MD
        • Sub-Investigator:
          • Catherine LOMBARD BOHAS, MD
        • Sub-Investigator:
          • Thomas WALTER, MD
      • Pierre-Bénite Cedex, France, 69495
        • Active, not recruiting
        • Centre Hospitalier Lyon Sud
      • Saint-Etienne, France, 42055
        • Recruiting
        • CHU de Saint-Etienne Hôpital Nord
        • Principal Investigator:
          • Pierre Fournel, MD
        • Sub-Investigator:
          • Claire Bosacki, MD
        • Sub-Investigator:
          • Jean-Philippe Jacquin, MD
        • Sub-Investigator:
          • Thierry Muron, MD
        • Sub-Investigator:
          • Romain RIVOIRARD, MD
        • Sub-Investigator:
          • Léa Saban-Roche, MD
        • Sub-Investigator:
          • Cécile Vassal, MD
        • Sub-Investigator:
          • Aline Guillot, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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). For biopsies, presence of at least one tumor lesion with a diameter ≥ 20 mm, visible by medical imaging and accessible to repeatable percutaneous (needle biopsies 18 gauge or larger) sampling that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication. Please note that brain and bone lesions are not considered as accessible lesions.
  • Patient with 1st, 2nd or 3rd line therapy (NB: endocrine therapy (monotherapy) are not considered as line therapy) for advanced / metastatic cancer.
  • For patients over 70 years of age, a Performance Status (PS) of 0 on the ECOG scale.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors.
Time Frame: at least 3 years after patient enrollment
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.
at least 3 years after patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish a map of immunologic profiles for all types of advanced malignant tumors.
Time Frame: at least 3 years after patient enrollment
Description of the incidence rates of each detected immunologic disorder in the global cohort and for each histological type.
at least 3 years after patient enrollment
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: at least 3 years after patient enrollment
Comparison of the genetic and immunologic profiles between patients with the same tumor type or between tumors of different types.
at least 3 years after patient enrollment
Identify genetic and/or immunologic biomarkers (or molecular profiles) with a potential predictive value on response to treatments.
Time Frame: at least 3 years after patient enrollment
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).
at least 3 years after patient enrollment
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: at least 3 years after patient enrollment
lymphopenia, over-representation of Treg, dendritic cells alterations,
at least 3 years after patient enrollment
Assess the changes of genetic and/or immunologic profiles in case of progressive disease
Time Frame: at least 3 years after patient enrollment
at least 3 years after patient enrollment
Number of patients with a recommanded therapy based on their molecular profil and/or for whom the therapy hs been administrated and description of the recommanded therapy
Time Frame: at least 3 years after patient enrollment
A description will be done of therapie(s) recommanded and/or received by patients based on recommandation done by the Molecular Tumor Board after reviewing of molecular profil
at least 3 years after patient enrollment
Describe the clinical impact of this molecular profiling in term of PFS
Time Frame: at least 3 years after patient enrollment
Progression free survival for each recommanded therapies received
at least 3 years after patient enrollment
Describe the clinical impact of this molecular profiling in term of OS
Time Frame: at least 3 years after patient enrollment
Overall survival for each recommanded therapies received
at least 3 years after patient enrollment
Describe the clinical impact of this molecular profiling in term of tumor response
Time Frame: at least 3 years after patient enrollment
Tumoral response (clinic and/or radiologic) for each recommanded therapies received
at least 3 years after patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Jean-Yves BLAY, MD PhD, Centre Leon Berard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 21, 2013

First Posted (Estimated)

January 24, 2013

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROFILER
  • ET12-082 (Other Identifier: Sponsor's number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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