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

Recruiting now

Conditions studied: Pancreas Adenocarcinoma, Small-cell Lung Cancer, Glioblastoma, IDH-wildtype

In brief

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.

Key facts

Study ID

NCT06160596

Run by

Cure 51

People needed

1020

Starts

2023-11-01

Expected to finish

2028-05-01

Last updated by the study team

2023-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

• Gustave Roussy Cancer Campus, Grand Paris — Villejuif, France (enrolling)

Full record on ClinicalTrials.gov

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