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| ID | Type | Description | Link |
|---|---|---|---|
| ET12-082 | Other Identifier | Sponsor's number |
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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.
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood and tumor samples | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and tumor samples | Genetic | Genetic: Establishment of the genetic and immunologic profile Whole blood sampling :
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a map of genetic profiles (for the pre-identified target genes) for all types of advanced malignant tumors. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Establish a map of immunologic profiles for all types of advanced malignant tumors. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Yves BLAY, MD | Contact | +33 4 78 78 51 26 | jean-yves.blay@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Yves BLAY, MD PhD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Annecy Genevois | Recruiting | Annecy | 74370 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19360079 | Background | Stratton MR, Campbell PJ, Futreal PA. The cancer genome. Nature. 2009 Apr 9;458(7239):719-24. doi: 10.1038/nature07943. | |
| 18282144 | Background | Diaz-Cano SJ. General morphological and biological features of neoplasms: integration of molecular findings. Histopathology. 2008 Jul;53(1):1-19. doi: 10.1111/j.1365-2559.2007.02937.x. Epub 2008 Feb 12. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
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. | 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 | 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 | 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 | 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 | 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 | 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 | Tumoral response (clinic and/or radiologic) for each recommanded therapies received | at least 3 years after patient enrollment |
| Groupement Hospitalier Mutualiste | Recruiting | Grenoble | 38028 | France |
|
| Hôpital Edouard Herriot | Not yet recruiting | Lyon | 69003 | France |
|
| Centre Léon Bérard | Recruiting | Lyon | 69008 | France |
|
| Centre Hospitalier Lyon Sud | Active, not recruiting | Pierre-Bénite | 69495 | France |
| CHU de Saint-Etienne Hôpital Nord | Recruiting | Saint-Etienne | 42055 | France |
|
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| 35050753 | Derived | Benezech S, Saintigny P, Attignon V, Pissaloux D, Paindavoine S, Faure-Conter C, Corradini N, Marec-Berard P, Bergeron C, Cassier P, Eberst L, Dufresne A, Wang Q, Agrapart V, De La Fouchardiere A, Perol D, Garin G, Corset V, Ben Abdesselem L, Chabaud S, Tredan O, Blay JY, Frappaz D. Tumor Molecular Profiling: Pediatric Results of the ProfiLER Study. JCO Precis Oncol. 2020 Nov;4:785-795. doi: 10.1200/PO.20.00023. |
| 30865223 | Derived | Tredan O, Wang Q, Pissaloux D, Cassier P, de la Fouchardiere A, Fayette J, Desseigne F, Ray-Coquard I, de la Fouchardiere C, Frappaz D, Heudel PE, Bonneville-Levard A, Flechon A, Sarabi M, Guibert P, Bachelot T, Perol M, You B, Bonnin N, Collard O, Leyronnas C, Attignon V, Baudet C, Sohier E, Villemin JP, Viari A, Boyault S, Lantuejoul S, Paindavoine S, Treillleux I, Rodriguez C, Agrapart V, Corset V, Garin G, Chabaud S, Perol D, Blay JY; ProfiLER investigators. Molecular screening program to select molecular-based recommended therapies for metastatic cancer patients: analysis from the ProfiLER trial. Ann Oncol. 2019 May 1;30(5):757-765. doi: 10.1093/annonc/mdz080. |
| 26317543 | Derived | Jiang X, Pissaloux D, De La Fouchardiere C, Desseigne F, Wang Q, Attignon V, Fondrevelle ME, De La Fouchardiere A, Perol M, Cassier P, Seigne C, Perol D, Ray-Coquard I, Meeus P, Fayette J, Flechon A, Le Cesne A, Penel N, Tredan O, Blay JY. The sum of gains and losses of genes encoding the protein tyrosine kinase targets predicts response to multi-kinase inhibitor treatment: Characterization, validation, and prognostic value. Oncotarget. 2015 Sep 22;6(28):26388-99. doi: 10.18632/oncotarget.4557. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |