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| Name | Class |
|---|---|
| Institut Bergonié | OTHER |
| Plateforme labellisée Inca - Institut Bergonié, Bordeaux | UNKNOWN |
| Plateforme labellisée Inca - Hôpital Européen Georges Pompidou, Paris | UNKNOWN |
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Next Generation Sequencing in cancer: a feasibility study in France to assess sample circuit and to perform analyzes within a limited time.
The first France disease genomic medicine program in the field of cancer has been retained by the 2025 Genomic Medicine France Plan. This program, called MULTIPLI encompasses two innovative personalized medicine clinical trials in soft-tissue sarcoma and colorectal carcinoma involving targeted molecules according to the tumor profile of each patient.
This 1st clinical research program aims implementing exome sequencing and RNA sequencing to determine the genomic profile and to provide a therapeutic decision for each patient. Genomic analyzes will be performed on different technical platforms: samples will be collected in each investigating center, nucleic acids extraction will be performed on two genetic platforms, Inca labeled and identified for the purpose of this study: Institut Bergonié and Hôpital Européen Georges Pompidou. CNRGH (Centre National de Recherche en Génomique Humaine) was retained for operational platform genomics and Institut Bergonie for bioinformatics data processing. Each genomic profile will be discussed within a multidisciplinary tumor board which aims at providing a therapeutic decision for each patient and to propose a targeted treatment in case of actionable molecular alteration.
The purpose of this program is to perform analysis on a set of gene, in order to provide results no more than after 6 weeks after the sample arrival on the biopathological platform. This gene panel analysis is based on the predefined list of genes that are direct targets of the drugs available in the MULTIPLI program.
Before implanting this program in a large-scale launch, it was essential to set up a pilot study in order to evaluate both sample's management between several platforms, and the time to report the results, and to verify that it was in line with the objectives set.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STS | Patients with advanced/metastatic soft-tissue sarcoma |
| |
| CCR | Patients with metastatic colorectal carcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Generation Sequencing (NGS): exome, RNA seq | Genetic | Tumor and blood samples will be sequenced at medium-high coverage at the whole genome (exome) and transcriptome levels (RNA Seq). This will allow detecting variants in a larger set of samples even though only from the main clone will be precisely measured. The whole exome will be performed at a mean coverage of at least 60x for the normal DNA samples and 120x for the tumor DNA samples. The transcriptome of the tumor will be performed at enough depth of coverage to detect gene fusions, transcriptome variants and measure the digital expression of already annotated isoforms. For both sequencing configurations:
|
| Measure | Description | Time Frame |
|---|---|---|
| Delay time to send a validated exome sequencing report from sample receipt | The time delay between the date of sample receipt by the platform and the date of dispatch of a validated MTB report to physician | an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of patients with samples received by Platform for whom a validated exome sequencing report is available | Rate of patients for whom a report was transmitted, within the patients for whom the samples were received by the platforms | Throughout the study period, on average of 3 months |
| Delay time to send a validated exome sequencing report from signature to informed consent by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included in this prospective cohort study are patients who have previously consented to tumor sequencing either as part of others studies or as part of standard care (voluntary signed informed consent). Two participating centers have been retained.
Samples used (blood and tumor) are issued from these previous collection and analyzed for the same purpose: no additional samples will be collected.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | 33076 | France | |||
| CEA / Centre National de Recherche en Génomique Humaine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32713836 | Result | FGM 2025 Workflow Study Group (Alliance nationale des Sciences de la Vie et de la Sante); Auzanneau C, Bacq D, Bellera C, Blons H, Boland A, Boucheix M, Bourdon A, Chollet E, Chomienne C, Deleuze JF, Delmas C, Dinart D, Esperou H, Geillon F, Geneste D, Italiano A, Jean D, Khalifa E, Laizet Y, Laurent-Puig P, Lethimonnier F, Levy-Marchal C, Lucchesi C, Malle C, Mancini P, Mathoulin-Pelissier S, Meyer V, Marie-Ange P, Perkins G, Sellan-Albert S, Soubeyran I, Wallet C. Feasibility of high-throughput sequencing in clinical routine cancer care: lessons from the cancer pilot project of the France Genomic Medicine 2025 plan. ESMO Open. 2020 Jul;5(4):e000744. doi: 10.1136/esmoopen-2020-000744. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059014 | High-Throughput Nucleotide Sequencing |
| D001483 | Base Sequence |
| ID | Term |
|---|---|
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D015394 | Molecular Structure |
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| CNRGH, Evry |
| UNKNOWN |
| EUCLID Clinical Trial Platform | OTHER |
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For each participant, biological specimens will be collected for molecular analysis :
|
The time delay between the date of informed consent signature and the date of dispatch of a validated MTB report to physician |
| an average of 8 weeks |
| The rate of patients with signed informed consent for whom a validated exome sequencing report is available | Rate of patients for whom a report was transmitted, within the patients for whom signed consent has been signed | Throughout the study period, on average of 3 months |
| Delay time to receive sample on Platform from signature of informed consent | The time delay between the date of informed consent signature and the date of sample receipt on platform | on average of 2 weeks |
| The rate of patients with signed informed consent for whom samples have been received by platform | Rate of patients for whom samples have been received by platform, within the patients for whom signed consent has been signed | Throughout the study period, on average of 3 months |
| Delay time to receipt nucleic acids on CNRGH from samples receipt on platform | The time delay between the date of sample receipt on platform and the date of nucleic acids receipt on CNRGH | on average of 1 week |
| The rate of patients with samples sending date completed on electronic case for whom samples have been received by platform | Rate of patients for whom samples have been received by platform, within the patients for whom sending date has been completed on electronic case | Throughout the study period, on average of 3 months |
| The rate of patients with samples received on platform for whom these samples have been qualified in first step by platform and nucleic acids have been received by CNRGH | Rate of patients for whom samples have been qualified in first step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform | Throughout the study period, on average of 3 months |
| The rate of patients with samples received on Platform for whom these samples have been qualified in second step by platform and nucleic acids have been received by CNRGH | Rate of patients for whom samples have been qualified in second step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform | Throughout the study period, on average of 3 months |
| The rate of patients with samples received on platform for whom these samples have been qualified in first and second step by Platform and nucleic acids have been received by CNRGH | Rate of patients for whom samples have been qualified in first and second step by platform and nucleic acids received by CNRGH, within the patients for whom samples have been received by platform | Throughout the study period, on average of 3 months |
| Delay time to receive all sequencing files from nucleic acids receipt on CNRGH | The time delay between the date of nucleic acids receipt on CNRGH and the date of receipt of all sequencing files by bioinformatic platform | on average of 3 weeks |
| The rate of patients with nucleic acids received on CNRGH for whom all sequencing files have been qualified by bioinformatics platform | Rate of patients for whom all sequencing files have been qualified by bioinformatics platform, within the patients for whom samples have been received by CNRGH | Throughout the study period, on average of 3 months |
| The rate of patients with nucleic acids received on CNRGH for whom sequencing have been qualified by CNRGH | Rate of patients for whom sequencing have been qualified by CNRGH, within the patients for whom samples have been received by CNRGH | Throughout the study period, on average of 3 months |
| Delay time to receive bioinformatics analysis for interpretation from availability of all sequencing files | The time delay between the date of receipt of all sequencing files by bioinformatics platform and the date of receipt of bioinformatics analysis by biologist for interpretation | on average of 1 week |
| The rate of patients with sequencing files received by bioinformatic Platform for whom these files have been qualified for analysis | Rate of patients for whom all sequencing file have been qualified by bioinformatic platform, within the patients for whom all sequencing file have been received by bioinformatic platform | Throughout the study period, on average of 3 months |
| The rate of patients with sequencing files received by bioinformatic Platform for whom analysis have been transmitted for interpretation | Rate of patients for whom bioinformatic analysis have been transmitted for interpretation, within the patients for whom all sequencing file have been received by bioinformatic platform | Throughout the study period, on average of 3 months |
| Delay time to send a validated exome sequencing report from availability of bioinformatic analysis | The time delay between the date of bioinformatic analysis availability for interpretation and the date of dispatch of a validated MTB report to physician | on average of 1 week |
| The rate of patients with bioinformatic analysis available for interpretation for whom biological interpretation has been performed | Rate of patients for whom bioinformatic analysis has been interpreted by biologist, within the patients for whom bioinformatics analysis have been transmitted | Throughout the study period, on average of 3 months |
| The rate of patients with bioinformatic analysis available for interpretation for whom results has been discussed by MTB | Rate of patients for whom biological report has been discussed by MTB, within the patients for whom bioinformatics analysis have been transmitted | Throughout the study period, on average of 3 months |
| Évry |
| 91057 |
| France |
| Hôpital Européen Georges Pompidou | Paris | 75000 | France |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D001669 |
| Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |