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RECRUITING

NCT06160596

Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis

Sponsor: Cure 51

View on ClinicalTrials.gov

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.

Official title: Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1020

Start Date

2023-11-01

Completion Date

2028-05-01

Last Updated

2023-12-07

Healthy Volunteers

Conditions

Pancreas Adenocarcinoma Small-cell Lung Cancer Glioblastoma, IDH-wildtype

Interventions

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)

Inclusion Criteria: FOR SURVIVORS * To be eligible the exceptional survivor patients must fulfill the following inclusion criteria: 1. Adult patient (≥18 years old at diagnosis). 2. Three distinct cohorts, one of patients harbouring metastatic pancreatic ductal adenocarcinoma, glioblastoma IDHwt, extensive small cell lung cancer. 3. 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. 4. 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 : * To be eligible the control patients must fulfill the following inclusion criteria: 1. ≥18 years old at diagnosis. 2. Three distinct cohorts, one of patients suffering from metastatic pancreatic ductal adenocarcinoma, one for glioblastoma, one for extensive small cell lung cancer. 3. Paired to long-term survivors as mentioned in the methodology section 4. Death or median overall survival with a variation of 10% before of beyond as reported in pivotal clinical trials in the specific type disease 5. 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). Exclusion Criteria for both groups : * Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria: 1. \<18 years old at diagnosis. 2. Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria. 3. Tumor sample not available or not reaching the required quality for multi-omic analyses.

Locations (1)

Gustave Roussy Cancer Campus, Grand Paris

Villejuif, France