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OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer
Sébastien Vachenc1, Jessica Gobbo2,3, Sarah El Moujarrebe4
1Oncodesign SA, 18-20 rue Jean Mazen, 21079, Dijon Cedex, France. svachenc@oncodesign.com.
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.
Insights
The OncoSNIPE study aims to identify early and late markers of treatment resistance in various cancers. Understanding these resistance mechanisms is crucial for developing new therapeutic strategies against cancer progression.
Area of Science:
- Oncology
- Genomics
- Clinical Research
Background:
- Current RECIST methodology for solid tumor monitoring has limitations in understanding diverse resistance mechanisms.
- Identifying early and late markers of treatment resistance is a critical unmet need in oncology.
Purpose of the Study:
- To identify early and late markers of treatment resistance in breast, lung, and pancreatic cancers.
- To understand the molecular mechanisms underlying treatment resistance and cancer progression.
Main Methods:
- A multicentric, interventional study involving 600 adult patients with advanced or metastatic cancers.
- Utilizing high-throughput sequencing (Exome-seq, RNAseq), clinical data, medical imaging, and immunological profiling (ELISA).
- Long-term patient follow-up with biological sample collection and detailed clinical data collection via CRF and SCDW.
Main Results:
- The study is ongoing, and results are pending.
- The cohort is designed to provide models for evaluating early and late response markers over a 2-year follow-up period.
Conclusions:
- Diverse molecular mechanisms contribute to treatment resistance, posing a significant therapeutic challenge.
- Improved understanding of resistance mechanisms can lead to novel therapeutic targets and strategies to overcome cancer escape.
