Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCure 51
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
One block sample must be of sufficient quality and in sufficient quantity to perform multi-omic analyses, according to requirements specified in Lab manual
Disqualifiers
<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.
Trial population
Primary and secondary care clinic, oncology centers
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Long term survival multimodal analysis
Genetic* 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)
Treatment groups
1,020 Participants
are divided into 3 treatment groupsGroup A: PDAC STAGE IV SURVIVORS & CONTROLS1 intervention
Group B: SMALL CELL LUNG CANCER EXTENSIVE STAGE SURVIVORS & CONTROLS1 intervention
Group C: GLIOBLASTOMA SURVIVORS & CONTROLS1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSponsors and contacts
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Cure 51
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Centre Leon Berard
Collaborator
Vall d'Hebron Institute of Oncology
Collaborator
Istituto Europeo di Oncologia
Collaborator
Charite University, Berlin, Germany
Collaborator
Source ClinicalTrials.gov