Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study
Cure 51
1,020 participants
Nov 1, 2023
OBSERVATIONAL
Conditions
Summary
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: * Cohort A: metastatic pancreatic ductal adenocarcinoma * Cohort B: glioblastoma IDHwt * Cohort C: extensive small cell lung cancer 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.
Eligibility
Inclusion Criteria18
- FOR SURVIVORS
- Adult patient (≥18 years old at diagnosis).
- Three distinct cohorts, one of patients harbouring metastatic pancreatic ductal adenocarcinoma, glioblastoma IDHwt, extensive small cell lung cancer.
- Long-term survival is defined as an exceptionally long survival ≥ 5 years from stage IV diagnosis for PDAC, extensive SCLC, and ≥ 3 years for GBM-IDHwt.
- Availability of at least one block sample and associated clinical annotations with following characteristics:
- One block sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses, according to requirements specified in Lab manual
- Any treatment prior to sample acquisition must be reported - all treatments accepted (standard / targeted);
- Samples should be at least 5 years old for PDAC and SCLC and 3 years old for GBM
- For CONTROL GROUPS :
- ≥18 years old at diagnosis.
- Three distinct cohorts, one of patients suffering from metastatic pancreatic ductal adenocarcinoma, one for glioblastoma, one for extensive small cell lung cancer.
- Paired to long-term survivors as mentioned in the methodology section
- Death or median overall survival with a variation of 10% before of beyond as reported in pivotal clinical trials in the specific type disease
- Availability of at least one tumor sample and associated clinical annotations with following characteristics:
- Sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses
- Any treatment prior to sample acquisition must be reported (treatment-naive samples should be preferred) - all treatments accepted (standard / targeted).
- \<18 years old at diagnosis.
- Tumor sample not available or not reaching the required quality for multi-omic analyses.
Interventions
* 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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06160596