Status:
RECRUITING
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
Lead Sponsor:
Cure 51
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
Centre Leon Berard
Conditions:
Pancreas Adenocarcinoma
Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
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 (cas...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- FOR SURVIVORS
- To be eligible the exceptional survivor patients must fulfill the following inclusion criteria:
- 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 :
- To be eligible the control patients must fulfill the following inclusion criteria:
- ≥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
- 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:
- \<18 years old at diagnosis.
- Hematological malignancy or solid tumors, which are not in the scope of tumor types, described in the inclusion criteria.
- Tumor sample not available or not reaching the required quality for multi-omic analyses.
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT06160596
Start Date
November 1 2023
End Date
May 1 2028
Last Update
December 7 2023
Active Locations (1)
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1
Gustave Roussy Cancer Campus, Grand Paris
Villejuif, France, 94805