Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
ROSALIND
1 other identifier
observational
1,020
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 29, 2023
CompletedFirst Posted
Study publicly available on registry
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
ExpectedDecember 7, 2023
November 1, 2023
2 years
November 29, 2023
November 29, 2023
Conditions
Outcome Measures
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.
54 months
Study Arms (3)
PDAC STAGE IV SURVIVORS & CONTROLS
Metastatic pancreatic ductal adenocarcinoma (PDAC) (Other histologies such as adenosquamous carcinoma, hepatoid carcinoma, anaplastic undifferentiated carcinoma and medullary carcinoma, acinar cell carcinoma, neuroendocrine tumors, Solid pseudopapillary neoplasm, Pancreatoblastoma, Serous cystadenocarcinoma are excluded)
SMALL CELL LUNG CANCER EXTENSIVE STAGE SURVIVORS & CONTROLS
Extensive small cell lung cancer (SCLC) (Other histologies excluded: combined SCLC with some areas of non-small cell lung cancer (NSCLC), carcinoid tumors, typical and atypical, large cell neuroendocrine carcinoma of the lung).
GLIOBLASTOMA SURVIVORS & CONTROLS
Glioblastoma (GBM) (IDH mutated excluded)
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)
Eligibility Criteria
Primary and secondary care clinic, oncology centers
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- \<18 years old at diagnosis.
- Tumor sample not available or not reaching the required quality for multi-omic analyses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cure 51lead
- Gustave Roussy, Cancer Campus, Grand Pariscollaborator
- Centre Leon Berardcollaborator
- Vall d'Hebron Institute of Oncologycollaborator
- Istituto Europeo di Oncologiacollaborator
- Charite University, Berlin, Germanycollaborator
Study Sites (1)
Gustave Roussy Cancer Campus, Grand Paris
Villejuif, 94805, France
Related Links
Biospecimen
Biopsies, surgical pieces, frozen plasma, blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julieta Rodriguez, MD
Gustave Roussy, Cancer Campus, Grand Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2023
First Posted
December 7, 2023
Study Start
November 1, 2023
Primary Completion
November 1, 2025
Study Completion (Estimated)
May 1, 2028
Last Updated
December 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
To be discussed internally and with the scientific advisory board later. All institutions providing patient data will have full access to multiomics sequencing raw data of their own patients for academic use.