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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

FOR SURVIVORS.
  • - To be eligible the exceptional survivor patients must fulfill the following 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 :
  • - To be eligible the control patients must fulfill the following

    inclusion criteria:

    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).
Exclusion Criteria for both groups :
  • - Patient must not be enrolled if he/she fulfils one of the following non-inclusion criteria: 1.
<18 years old at diagnosis. 2. Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria. 3. Tumor sample not available or not reaching the required quality for multi-omic analyses.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06160596
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cure 51
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Julieta Rodriguez, MD
Principal Investigator Affiliation Gustave Roussy, Cancer Campus, Grand Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pancreas Adenocarcinoma, Small-cell Lung Cancer, Glioblastoma, IDH-wildtype
Study Website: View Trial Website
Additional Details

We propose for the first time to build a large collection of samples from unexpected survivors and controls with standard survival to identify biomarkers of resistance and/or survival which would help developing new cancer therapeutics. Biological samples and clinical records will be collected and then centralised to extract the data of any patients who have survived more than 5 years for the cohorts of PDAC and SCLC and more than 3 years for the cohort of GMB-IDHwt from the day of diagnosis. In addition to the clinical record of the patient describing his/her history (including multiscale imaging, pathology, biological sample analysis), we will collect every point of data possible with current technologies, such as multi-omics including genome, proteome, transcriptome, epigenomic, metabolome and microbiome. The data set of these multi-omic groups are combined and are complementary to identify a certain biological function and its cellular source. Such complementary effects and synergistic interactions between omic layers in the life course can only be captured by integrative study of multiple molecular layers. Artificial intelligence (AI), specifically machine learning algorithms, will also help to understand these multi-omics data. AI can also bring a new layer of biomarker discovery enabling the analysis of whole slide images of biopsies with computer vision and linking those biomarkers to the multi omics genomic features. After interpreting the comprehensive data with our set-up bioinformatics team in coordination with the various centres, we expect to find molecular signatures and consequently therapeutic approaches to address patients and physicians unmet needs.

Arms & Interventions

Arms

: 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

Genetic: - 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)

Contact a Trial Team

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International Sites

Villejuif, France

Status

Recruiting

Address

Gustave Roussy Cancer Campus, Grand Paris

Villejuif, , 94805

Site Contact

Julieta Rodriguez, MD

Julieta.RODRIGUEZ@gustaveroussy.fr

0033644803131

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