An observational study in Pancreas Adenocarcinoma, Small-cell Lung Cancer and Glioblastoma, IDH-wildtype, sponsored by Cure 51. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Cure 51 · Observational
This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival.
Patients with:
This research aims to integrate data generated from clinical records, imaging, multi-omics and bioinformatics approaches to discriminate case and control and then to identify new therapeutic targets. Analyses will be performed depending on the tumor samples available with at least 3 omics levels and according to scientific advances; genomic, epigenomic, proteomics, metabolomics, transcriptomic, microbiomic.
We propose for the first time to build a large collection of samples from unexpected survivors and controls with standard survival to identify biomarkers of resistance and/or survival which would help developing new cancer therapeutics. Biological samples and clinical records will be collected and then centralised to extract the data of any patients who have survived more than 5 years for the cohorts of PDAC and SCLC and more than 3 years for the cohort of GMB-IDHwt from the day of diagnosis. In addition to the clinical record of the patient describing his/her history (including multiscale imaging, pathology, biological sample analysis), we will collect every point of data possible with current technologies, such as multi-omics including genome, proteome, transcriptome, epigenomic, metabolome and microbiome. The data set of these multi-omic groups are combined and are complementary to identify a certain biological function and its cellular source. Such complementary effects and synergistic interactions between omic layers in the life course can only be captured by integrative study of multiple molecular layers. Artificial intelligence (AI), specifically machine learning algorithms, will also help to understand these multi-omics data. AI can also bring a new layer of biomarker discovery enabling the analysis of whole slide images of biopsies with computer vision and linking those biomarkers to the multi omics genomic features. After interpreting the comprehensive data with our set-up bioinformatics team in coordination with the various centres, we expect to find molecular signatures and consequently therapeutic approaches to address patients and physicians unmet needs.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 1,020 is above the median of 60 across 188 observational studies indexed under Glioblastoma.
Browse Glioblastoma studies →This is the only study on the registry with Cure 51 as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Primary and secondary care clinic, oncology centers
FOR SURVIVORS
To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:
Availability of at least one block sample and associated clinical annotations with following characteristics:
For CONTROL GROUPS :
To be eligible the control patients must fulfill the following inclusion criteria:
Availability of at least one tumor sample and associated clinical annotations with following characteristics:
Exclusion Criteria for both groups :
Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria:
Metastatic pancreatic ductal adenocarcinoma (PDAC) (Other histologies such as adenosquamous carcinoma, hepatoid carcinoma, anaplastic undifferentiated carcinoma and medullary carcinoma, acinar cell carcinoma, neuroendocrine tumors, Solid pseudopapillary neoplasm, Pancreatoblastoma, Serous cystadenocarcinoma are excluded)
Genetic: Long term survival multimodal analysis
Extensive small cell lung cancer (SCLC) (Other histologies excluded: combined SCLC with some areas of non-small cell lung cancer (NSCLC), carcinoid tumors, typical and atypical, large cell neuroendocrine carcinoma of the lung).
Genetic: Long term survival multimodal analysis
Glioblastoma (GBM) (IDH mutated excluded)
Genetic: Long term survival multimodal analysis
* To describe global signatures (Digital histology, Radiomic, Genomic, Transcriptomic, Proteomic, (Epigenomic) and clinical signature) that are associated with a patient's unexpected survival compared to standard patients across three cohorts of solid tumors with unmet medical needs. * To describe global signatures in the overall population (pan-cohort). * To describe clinical, digital pathology, radiomic, genomic, transcriptomic, proteomic and epigenomic signatures associated with patients' unexpected survival compared to standard patients for each cohort and in all cohorts (pan-cohort)
EXCEPTIONAL SURVIVAL
In this study, the primary endpoint is the long survivorship status (Y/N). Prior to locking the database, a data review meeting will be planned to review individual data and validate the Statistical Analysis Plan (SAP). All the deviations from protocol definitions (if any) will be listed and defined as major or minor deviations in the SAP.
Time frame: 54 months
Plan to share: No — To be discussed internally and with the scientific advisory board later. All institutions providing patient data will have full access to multiomics sequencing raw data of their own patients for academic use.
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