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

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ClinicalTrials.gov Identifier: NCT01774409
Recruitment Status : Recruiting
First Posted : January 24, 2013
Last Update Posted : April 11, 2022
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Neoplasms Genetic: Blood and tumor samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2013
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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,

  5. Assess the changes of genetic and/or immunologic profiles in case of progressive disease [ Time Frame: at least 3 years after patient enrollment ]
  6. 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

  7. 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

  8. 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

  9. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774409

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

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Centre Hospitalier Annecy Genevois Recruiting
Annecy, France, 74370
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         
Groupement Hospitalier Mutualiste Recruiting
Grenoble, France, 38028
Principal Investigator: Cécile LEYRONNAS, 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 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: Hervé GHESQUIERES, MD         
Sub-Investigator: Jean-Paul GUASTALLA, MD         
Sub-Investigator: Pierre GUIBERT, MD         
Sub-Investigator: Pierre-Etienne HEUDEL, 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         
Centre Hospitalier Lyon Sud Active, not recruiting
Pierre-Bénite Cedex, France, 69495
CHU de Saint-Etienne Hôpital Nord Recruiting
Saint-Etienne, France, 42055
Principal Investigator: Pierre Fournel, MD         
Sub-Investigator: Claire Bosacki, MD         
Sub-Investigator: Aline Guillot, 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         
Sponsors and Collaborators
Centre Leon Berard
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Principal Investigator: Jean-Yves BLAY, MD PhD Centre Leon Berard
International Cancer Genome Consortium, Hudson TJ, Anderson W, Artez A, Barker AD, Bell C, Bernabé RR, Bhan MK, Calvo F, Eerola I, Gerhard DS, Guttmacher A, Guyer M, Hemsley FM, Jennings JL, Kerr D, Klatt P, Kolar P, Kusada J, Lane DP, Laplace F, Youyong L, Nettekoven G, Ozenberger B, Peterson J, Rao TS, Remacle J, Schafer AJ, Shibata T, Stratton MR, Vockley JG, Watanabe K, Yang H, Yuen MM, Knoppers BM, Bobrow M, Cambon-Thomsen A, Dressler LG, Dyke SO, Joly Y, Kato K, Kennedy KL, Nicolás P, Parker MJ, Rial-Sebbag E, Romeo-Casabona CM, Shaw KM, Wallace S, Wiesner GL, Zeps N, Lichter P, Biankin AV, Chabannon C, Chin L, Clément B, de Alava E, Degos F, Ferguson ML, Geary P, Hayes DN, Hudson TJ, Johns AL, Kasprzyk A, Nakagawa H, Penny R, Piris MA, Sarin R, Scarpa A, Shibata T, van de Vijver M, Futreal PA, Aburatani H, Bayés M, Botwell DD, Campbell PJ, Estivill X, Gerhard DS, Grimmond SM, Gut I, Hirst M, López-Otín C, Majumder P, Marra M, McPherson JD, Nakagawa H, Ning Z, Puente XS, Ruan Y, Shibata T, Stratton MR, Stunnenberg HG, Swerdlow H, Velculescu VE, Wilson RK, Xue HH, Yang L, Spellman PT, Bader GD, Boutros PC, Campbell PJ, Flicek P, Getz G, Guigó R, Guo G, Haussler D, Heath S, Hubbard TJ, Jiang T, Jones SM, Li Q, López-Bigas N, Luo R, Muthuswamy L, Ouellette BF, Pearson JV, Puente XS, Quesada V, Raphael BJ, Sander C, Shibata T, Speed TP, Stein LD, Stuart JM, Teague JW, Totoki Y, Tsunoda T, Valencia A, Wheeler DA, Wu H, Zhao S, Zhou G, Stein LD, Guigó R, Hubbard TJ, Joly Y, Jones SM, Kasprzyk A, Lathrop M, López-Bigas N, Ouellette BF, Spellman PT, Teague JW, Thomas G, Valencia A, Yoshida T, Kennedy KL, Axton M, Dyke SO, Futreal PA, Gerhard DS, Gunter C, Guyer M, Hudson TJ, McPherson JD, Miller LJ, Ozenberger B, Shaw KM, Kasprzyk A, Stein LD, Zhang J, Haider SA, Wang J, Yung CK, Cros A, Liang Y, Gnaneshan S, Guberman J, Hsu J, Bobrow M, Chalmers DR, Hasel KW, Joly Y, Kaan TS, Kennedy KL, Knoppers BM, Lowrance WW, Masui T, Nicolás P, Rial-Sebbag E, Rodriguez LL, Vergely C, Yoshida T, Grimmond SM, Biankin AV, Bowtell DD, Cloonan N, deFazio A, Eshleman JR, Etemadmoghadam D, Gardiner BB, Kench JG, Scarpa A, Sutherland RL, Tempero MA, Waddell NJ, Wilson PJ, McPherson JD, Gallinger S, Tsao MS, Shaw PA, Petersen GM, Mukhopadhyay D, Chin L, DePinho RA, Thayer S, Muthuswamy L, Shazand K, Beck T, Sam M, Timms L, Ballin V, Lu Y, Ji J, Zhang X, Chen F, Hu X, Zhou G, Yang Q, Tian G, Zhang L, Xing X, Li X, Zhu Z, Yu Y, Yu J, Yang H, Lathrop M, Tost J, Brennan P, Holcatova I, Zaridze D, Brazma A, Egevard L, Prokhortchouk E, Banks RE, Uhlén M, Cambon-Thomsen A, Viksna J, Ponten F, Skryabin K, Stratton MR, Futreal PA, Birney E, Borg A, Børresen-Dale AL, Caldas C, Foekens JA, Martin S, Reis-Filho JS, Richardson AL, Sotiriou C, Stunnenberg HG, Thoms G, van de Vijver M, van't Veer L, Calvo F, Birnbaum D, Blanche H, Boucher P, Boyault S, Chabannon C, Gut I, Masson-Jacquemier JD, Lathrop M, Pauporté I, Pivot X, Vincent-Salomon A, Tabone E, Theillet C, Thomas G, Tost J, Treilleux I, Calvo F, Bioulac-Sage P, Clément B, Decaens T, Degos F, Franco D, Gut I, Gut M, Heath S, Lathrop M, Samuel D, Thomas G, Zucman-Rossi J, Lichter P, Eils R, Brors B, Korbel JO, Korshunov A, Landgraf P, Lehrach H, Pfister S, Radlwimmer B, Reifenberger G, Taylor MD, von Kalle C, Majumder PP, Sarin R, Rao TS, Bhan MK, Scarpa A, Pederzoli P, Lawlor RA, Delledonne M, Bardelli A, Biankin AV, Grimmond SM, Gress T, Klimstra D, Zamboni G, Shibata T, Nakamura Y, Nakagawa H, Kusada J, Tsunoda T, Miyano S, Aburatani H, Kato K, Fujimoto A, Yoshida T, Campo E, López-Otín C, Estivill X, Guigó R, de Sanjosé S, Piris MA, Montserrat E, González-Díaz M, Puente XS, Jares P, Valencia A, Himmelbauer H, Quesada V, Bea S, Stratton MR, Futreal PA, Campbell PJ, Vincent-Salomon A, Richardson AL, Reis-Filho JS, van de Vijver M, Thomas G, Masson-Jacquemier JD, Aparicio S, Borg A, Børresen-Dale AL, Caldas C, Foekens JA, Stunnenberg HG, van't Veer L, Easton DF, Spellman PT, Martin S, Barker AD, Chin L, Collins FS, Compton CC, Ferguson ML, Gerhard DS, Getz G, Gunter C, Guttmacher A, Guyer M, Hayes DN, Lander ES, Ozenberger B, Penny R, Peterson J, Sander C, Shaw KM, Speed TP, Spellman PT, Vockley JG, Wheeler DA, Wilson RK, Hudson TJ, Chin L, Knoppers BM, Lander ES, Lichter P, Stein LD, Stratton MR, Anderson W, Barker AD, Bell C, Bobrow M, Burke W, Collins FS, Compton CC, DePinho RA, Easton DF, Futreal PA, Gerhard DS, Green AR, Guyer M, Hamilton SR, Hubbard TJ, Kallioniemi OP, Kennedy KL, Ley TJ, Liu ET, Lu Y, Majumder P, Marra M, Ozenberger B, Peterson J, Schafer AJ, Spellman PT, Stunnenberg HG, Wainwright BJ, Wilson RK, Yang H. International network of cancer genome projects. Nature. 2010 Apr 15;464(7291):993-8. doi: 10.1038/nature08987. Erratum in: Nature. 2010 Jun 17;465(7300):966. Himmelbaue, Heinz [corrected to Himmelbauer, Heinz]; Gardiner, Brooke A [corrected to Gardiner, Brooke B]; Cross, Anthony [corrected to Cros, Anthony].

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01774409    
Other Study ID Numbers: PROFILER
ET12-082 ( Other Identifier: Sponsor's number )
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Keywords provided by Centre Leon Berard:
all advanced malignant tumor