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

This study is not yet open for participant recruitment.

Verified January 2013 by Centre Leon Berard

Sponsor:

Information provided by (Responsible Party):

Centre Leon Berard

ClinicalTrials.gov Identifier:

NCT01774409

First received: January 16, 2013

Last updated: January 21, 2013

Last verified: January 2013

History of Changes

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 in the Centre Leon Berard 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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 2016
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 the patient has not progressed since the last treatment. •If there's no available sample or in case of progressive disease, the investigator will prescribe a biopsy of a reachable lesion (2 samples must be collected: a frozen one and a FFPE one). With the established profile, recommendations will be given by a multidisciplinary molecular board.

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 the patient has not progressed since the last treatment.

•If there's no available sample or in case of progressive disease, the investigator will prescribe a biopsy of a reachable lesion (2 samples must be collected: a frozen one and a FFPE one).

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years
Histologically or cytologically confirmed diagnosis of the advanced malignant tumor of any histological type (locally advanced tumor)

Tumor sample available to determine the genetic profile:

either archival tumor sample if available [frozen or FFPE (formalin fixed and paraffin embedded) AND with no progression of the disease since the last treatment;
or perform a new biopsy on a reachable lesion (determined by the oncologist and/or the radiologist) to collect a fresh sample if no sample is available OR in case of progressive disease. Especially for this case, the establishment of the genetic profile must be performed on a tumor sample which corresponds to the disease stage during the last treatment.
Patient must be covered by a medical insurance.
Informed consent signed.

Exclusion Criteria:

No archival tumor sample available and non-biopsiable disease.

Contacts and Locations

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

Contacts

Contact: Christelle SEIGNE, PhD	+33 4 26 55 68 47	christelle.seigne@lyon.unicancer.fr
Contact: Mathilde BERNARDIN	+33 4 26 55 68 11	mathilde.bernardin@lyon.unicancer.fr

Locations

France
Centre Léon Bérard	Not yet 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
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

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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:	January 21, 2013
Health Authority:	France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by Centre Leon Berard:

all advanced malignant tumor

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013

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