Informations générales (source: ClinicalTrials.gov)

NCT06160596 En recrutement IDF
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study
Observational
  • Glioblastome
  • Carcinome pulmonaire à petites cellules
novembre 2023
mai 2028
15 septembre 2025
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.
 Voir le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY Julieta Rodriguez, MD En recrutement IDF Contact (sur clinicalTrials)

Critères

Tous
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.