Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
NCT ID: NCT06160596
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1020 participants
OBSERVATIONAL
2023-11-01
2028-05-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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)
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)
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).
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)
GLIOBLASTOMA SURVIVORS & CONTROLS
Glioblastoma (GBM) (IDH mutated excluded)
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)
Interventions
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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)
Eligibility Criteria
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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 :
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).
1. \<18 years old at diagnosis.
3. Tumor sample not available or not reaching the required quality for multi-omic analyses.
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Centre Leon Berard
OTHER
Vall d'Hebron Institute of Oncology
OTHER
Istituto Europeo di Oncologia
OTHER
Charite University, Berlin, Germany
OTHER
Cure 51
OTHER
Responsible Party
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Principal Investigators
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Julieta Rodriguez, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Gustave Roussy Cancer Campus, Grand Paris
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Julieta Rodriguez, MD
Role: primary
Christophe Javaud
Role: backup
Related Links
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corporate website of sponsor
Other Identifiers
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2022-A02541-42
Identifier Type: -
Identifier Source: org_study_id