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

BMC Cancer

Roman Bruno¹  Fabien Pierrat¹  Nelson Dusetti²  Isabelle Desmoulins³  Romain Boidot³  Aurélie Bertaut³  Adèle Cueff³  Jessica Gobbo⁴  Michelle Beau-Faller⁵  Nicolas Girard⁶  Marine Gilabert⁷  Emmanuel Mitry⁷  Juan L. Iovanna⁸  Sébastien Vachenc⁹  Sarah El Moujarrebe⁹  Rahima Yousfi⁹  Philippe Genne⁹ 

[1] Acobiom SAS, 1682 rue de la Valsière Cap Delta Biopôle Euromédecine II, 34790, Grables, France;Cancer Research Center of Marseille, CRCM, Inserm, CNRS, Paoli-Calmettes Institut, Aix-Marseille University, Marseille, France;Centre Georges-François Leclerc, 1 rue Professeur Marion, 21079, Dijon Cedex, France;Centre Georges-François Leclerc, 1 rue Professeur Marion, 21079, Dijon Cedex, France;Inserm 1231, 8 Boulevard Jeanne d’ARC, 21000, Dijon, France;Hôpitaux Universitaires de Strasbourg, Avenue Molière, 67000, Strasbourg, France;Institut Curie, 26 Rue d’Ulm, 75005, Paris, France;Institut Paoli-Calmettes, 232 Bd de Sainte Marguerite, 13009, Marseille, France;Institut Paoli-Calmettes, 232 Bd de Sainte Marguerite, 13009, Marseille, France;Cancer Research Center of Marseille, CRCM, Inserm, CNRS, Paoli-Calmettes Institut, Aix-Marseille University, Marseille, France;Oncodesign SA, 18-20 rue Jean Mazen, 21079, Dijon Cedex, France;

关键词: Early/ late resistance marker;    NGS;    Immunological profile;    Triple negative breast or Luminal Breast Cancer;    Non small-cell lung cancer;    Pancreatic ductal adenocarcinoma;   

DOI  :  10.1186/s12885-021-09134-3

来源: Springer

【 摘 要 】

BackgroundNowadays, 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.MethodsMulticentric, 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.DiscussionThe 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 registrationClinicaltrial.gov. Registered 16 September 2020, https://clinicaltrials.gov/ct2/show/NCT04548960?term=oncosnipe&draw=2&rank=1 and ANSM ID RCB 2017-A02018-45.

【 授权许可】

CC BY