NCT06160596 Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
| NCT ID | NCT06160596 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cure 51 |
| Condition | Pancreas Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,020 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,020 participants in total. It began in 2023-11-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Julieta Rodriguez, MD
PRINCIPAL INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Frequently Asked Questions
Who can join the NCT06160596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreas Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06160596 currently recruiting?
Yes, NCT06160596 is actively recruiting participants. Contact the research team at nicolas@cure51.com for enrollment information.
Where is the NCT06160596 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT06160596 clinical trial?
NCT06160596 is sponsored by Cure 51. The principal investigator is Julieta Rodriguez, MD at Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 1,020 participants.