Analyzing long-term survivors of aggressive solid tumors

Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis: A 3 Cohorts Case Control Matched Study

This study looks at patients who have survived much longer than expected from aggressive solid tumors to see what makes them different and if it can help develop new treatments.

Quick facts

• Study type: Observational
• Enrollment: 1020 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cure 51 (Academic / other)
• Locations: 1 site (Villejuif)
• Trial ID: NCT06160596 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the characteristics of exceptional long-term survivors of solid tumors with poor prognosis, including pancreatic adenocarcinoma, glioblastoma IDH-wildtype, and extensive small-cell lung cancer. It will utilize a retrospective, multi-center approach to collect and analyze clinical records, imaging, and multi-omics data from patients who have survived significantly longer than expected. The goal is to identify biomarkers of resistance and survival that could lead to new therapeutic targets. Advanced technologies, including artificial intelligence, will be employed to interpret the complex data generated from these analyses.

Who should consider this trial

Good fit: Ideal candidates are adult patients aged 18 and older who have survived more than 5 years with metastatic pancreatic ductal adenocarcinoma or extensive small-cell lung cancer, or more than 3 years with glioblastoma IDH-wildtype.

Not a fit: Patients who do not meet the long-term survival criteria or those with other types of tumors will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the discovery of new therapeutic targets that improve treatment outcomes for patients with aggressive solid tumors.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in identifying biomarkers in cancer, suggesting potential for success.

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.

Where this trial is running

Villejuif

• Gustave Roussy Cancer Campus, Grand Paris — Villejuif, France (Recruiting)

Study contacts

• Principal investigator: Julieta Rodriguez, MD — Gustave Roussy, Cancer Campus, Grand Paris
• Study coordinator: Wolikow Nicolas, Master

Conditions Pancreas Adenocarcinoma; Small-cell Lung Cancer; Glioblastoma, IDH-wildtype