Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
Recruiting · NCT06160596 · Observational (researchers observe without assigning treatment) · Lead sponsor: Cure 51
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- FOR SURVIVORS
- To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:
- 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 :
- To be eligible the control patients must fulfill the following inclusion criteria:
- ≥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).
Exclusion criteria
- for both groups :
- Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria:
- \<18 years old at diagnosis.
- Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria.
- Tumor sample not available or not reaching the required quality for multi-omic analyses.
Where it is running
1 location listed.
- Gustave Roussy Cancer Campus, Grand Paris - Villejuif, France