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OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients

BACKGROUND: Nowadays, evaluation of the efficacy and the duration of treatment, in context of monitoring patients with solid tumors, is based on the RECIST methodology. With these criteria, resistance and/or insensitivity are defined as tumor non-response which does not allow a good understanding of...

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Autores principales: Vachenc, Sébastien, Gobbo, Jessica, Moujarrebe, Sarah El, Desmoulins, Isabelle, Gilabert, Marine, Beau-Faller, Michelle, Mitry, Emmanuel, Girard, Nicolas, Bertaut, Aurélie, Dusetti, Nelson, Iovanna, Juan L., Yousfi, Rahima, Pierrat, Fabien, Bruno, Roman, Cueff, Adèle, Boidot, Romain, Genne, Philippe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734369/
https://www.ncbi.nlm.nih.gov/pubmed/34991520
http://dx.doi.org/10.1186/s12885-021-09134-3
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author Vachenc, Sébastien
Gobbo, Jessica
Moujarrebe, Sarah El
Desmoulins, Isabelle
Gilabert, Marine
Beau-Faller, Michelle
Mitry, Emmanuel
Girard, Nicolas
Bertaut, Aurélie
Dusetti, Nelson
Iovanna, Juan L.
Yousfi, Rahima
Pierrat, Fabien
Bruno, Roman
Cueff, Adèle
Boidot, Romain
Genne, Philippe
author_facet Vachenc, Sébastien
Gobbo, Jessica
Moujarrebe, Sarah El
Desmoulins, Isabelle
Gilabert, Marine
Beau-Faller, Michelle
Mitry, Emmanuel
Girard, Nicolas
Bertaut, Aurélie
Dusetti, Nelson
Iovanna, Juan L.
Yousfi, Rahima
Pierrat, Fabien
Bruno, Roman
Cueff, Adèle
Boidot, Romain
Genne, Philippe
author_sort Vachenc, Sébastien
collection PubMed
description BACKGROUND: Nowadays, evaluation of the efficacy and the duration of treatment, in context of monitoring patients with solid tumors, is based on the RECIST methodology. With these criteria, resistance and/or insensitivity are defined as tumor non-response which does not allow a good understanding of the diversity of the underlying mechanisms. The main objective of the OncoSNIPE® collaborative clinical research program is to identify early and late markers of resistance to treatment. METHODS: Multicentric, interventional study with the primary objective to identify early and / or late markers of resistance to treatment, in 600 adult patients with locally advanced or metastatic triple negative or Luminal B breast cancer, non-small-cell lung cancer or pancreatic ductal adenocarcinoma. Patients targeted in this study have all rapid progression of their pathology, making it possible to obtain models for evaluating markers of early and / or late responses over the 2-year period of follow-up, and thus provide the information necessary to understand resistance mechanisms. To explore the phenomena of resistance, during therapeutic response and / or progression of the pathology, we will use a multidisciplinary approach including high-throughput sequencing (Exome-seq and RNAseq), clinical data, medical images and immunological profile by ELISA. Patients will have long-term follow-up with different biological samples, at baseline (blood and biopsy) and at each tumoral evaluation or tumoral progression evaluated by medical imaging. Clinical data will be collected through a dedicated Case Report Form (CRF) and enriched by semantic extraction based on the French ConSoRe (Continuum Soins Recherche) initiative, a dedicated Semantic Clinical Data Warehouse (SCDW) to cancer. The study is sponsored by Oncodesign (Dijon, France) and is currently ongoing. DISCUSSION: The great diversity of intrinsic or acquired molecular mechanisms involved in resistance to treatment constitutes a real therapeutic issue. Improving understanding of mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major challenge. The OncoSNIPE cohort will lead to a better understanding of the mechanisms of resistance and will allow to explore new mechanisms of actions and to discover new therapeutic targets or strategies making it possible to circumvent the escape in different types of cancer. TRIAL REGISTRATION: Clinicaltrial.gov. Registered 16 September 2020, https://clinicaltrials.gov/ct2/show/NCT04548960?term=oncosnipe&draw=2&rank=1 and ANSM ID RCB 2017-A02018-45.
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spelling pubmed-87343692022-01-07 OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients Vachenc, Sébastien Gobbo, Jessica Moujarrebe, Sarah El Desmoulins, Isabelle Gilabert, Marine Beau-Faller, Michelle Mitry, Emmanuel Girard, Nicolas Bertaut, Aurélie Dusetti, Nelson Iovanna, Juan L. Yousfi, Rahima Pierrat, Fabien Bruno, Roman Cueff, Adèle Boidot, Romain Genne, Philippe BMC Cancer Study Protocol BACKGROUND: Nowadays, evaluation of the efficacy and the duration of treatment, in context of monitoring patients with solid tumors, is based on the RECIST methodology. With these criteria, resistance and/or insensitivity are defined as tumor non-response which does not allow a good understanding of the diversity of the underlying mechanisms. The main objective of the OncoSNIPE® collaborative clinical research program is to identify early and late markers of resistance to treatment. METHODS: Multicentric, interventional study with the primary objective to identify early and / or late markers of resistance to treatment, in 600 adult patients with locally advanced or metastatic triple negative or Luminal B breast cancer, non-small-cell lung cancer or pancreatic ductal adenocarcinoma. Patients targeted in this study have all rapid progression of their pathology, making it possible to obtain models for evaluating markers of early and / or late responses over the 2-year period of follow-up, and thus provide the information necessary to understand resistance mechanisms. To explore the phenomena of resistance, during therapeutic response and / or progression of the pathology, we will use a multidisciplinary approach including high-throughput sequencing (Exome-seq and RNAseq), clinical data, medical images and immunological profile by ELISA. Patients will have long-term follow-up with different biological samples, at baseline (blood and biopsy) and at each tumoral evaluation or tumoral progression evaluated by medical imaging. Clinical data will be collected through a dedicated Case Report Form (CRF) and enriched by semantic extraction based on the French ConSoRe (Continuum Soins Recherche) initiative, a dedicated Semantic Clinical Data Warehouse (SCDW) to cancer. The study is sponsored by Oncodesign (Dijon, France) and is currently ongoing. DISCUSSION: The great diversity of intrinsic or acquired molecular mechanisms involved in resistance to treatment constitutes a real therapeutic issue. Improving understanding of mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major challenge. The OncoSNIPE cohort will lead to a better understanding of the mechanisms of resistance and will allow to explore new mechanisms of actions and to discover new therapeutic targets or strategies making it possible to circumvent the escape in different types of cancer. TRIAL REGISTRATION: Clinicaltrial.gov. Registered 16 September 2020, https://clinicaltrials.gov/ct2/show/NCT04548960?term=oncosnipe&draw=2&rank=1 and ANSM ID RCB 2017-A02018-45. BioMed Central 2022-01-06 /pmc/articles/PMC8734369/ /pubmed/34991520 http://dx.doi.org/10.1186/s12885-021-09134-3 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Vachenc, Sébastien
Gobbo, Jessica
Moujarrebe, Sarah El
Desmoulins, Isabelle
Gilabert, Marine
Beau-Faller, Michelle
Mitry, Emmanuel
Girard, Nicolas
Bertaut, Aurélie
Dusetti, Nelson
Iovanna, Juan L.
Yousfi, Rahima
Pierrat, Fabien
Bruno, Roman
Cueff, Adèle
Boidot, Romain
Genne, Philippe
OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title_full OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title_fullStr OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title_full_unstemmed OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title_short OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
title_sort oncosnipe® study protocol, a study of molecular profiles associated with development of resistance in solid cancer patients
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8734369/
https://www.ncbi.nlm.nih.gov/pubmed/34991520
http://dx.doi.org/10.1186/s12885-021-09134-3
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