Profiling cancer patients using tumor and blood samples
A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies
NA · Centre Leon Berard · NCT05099068
This study is testing how analyzing tumor and blood samples from advanced cancer patients over time can help doctors understand how the cancer changes and find better treatment options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Leon Berard (other) |
| Drugs / interventions | avelumab, cetuximab, Imatinib, trametinib, Selpercatinib, chemotherapy, Immunotherapy |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT05099068 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze the molecular profiles and biological characteristics of patients with advanced cancer through longitudinal assessments of tumor and liquid biopsies. By examining these samples over time, the study seeks to develop predictive models for tumor response and resistance, enhancing the understanding of cancer evolution and treatment adaptation. Patients will be enrolled prior to starting standard anti-cancer treatments, and their biological data will be reviewed by a Molecular Tumor Board to inform potential therapeutic options as their disease progresses.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed diagnoses of advanced or metastatic solid tumors who are about to begin standard anti-cancer treatment.
Not a fit: Patients with early-stage cancer or those not eligible for standard anti-cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with advanced cancer.
How similar studies have performed: Other studies have shown promise in using molecular profiling for personalized therapy, but this approach is still evolving and may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: I1. Adult male or female patient with confirmed diagnosis of advanced/metastatic cancer to be treated with standard anti-cancer treatment according to : * For metastatic Small cell lung cancer (SLCC) : treatment by Immunotherapy ± chemotherapy * For Recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC) : treatment by Immunotherapy (all lines) ± chemotherapy if in agreement with SmPC * For Metastatic Urothelial carcinoma : treatment by 1st line chemotherapy with avelumab as maintenance treatment (patients will be enrolled following 4 to 6 cycles of CT, only patient initiating avelumab maintenance are eligible (i.e. patients with SD or PR after CT) * For MSI-High, any tumor types : treatment by Immunotherapy * For HPV-related cancers, any tumor types : treatment by Immunotherapy * Metastatic GIST : treatment by Imatinib * BRAF- V600E tumors (lung and thyroid cancer) : treatment by Dabrafenib + trametinib * BRAF- mutated tumors (CRC, lung and thyroid cancer) : Lung (V600E only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib): treatment by Dabrafenib + trametinib CRC (BRAF V600E): treatment by Encorafenib + cetuximab * All solid tumor types with ret fusion / mutation : treatment by Selpercatinib * Metastatic Triple negative breast cancer (TNBC) : treatment by 1st line chemotherapy * Glioblastoma : treatment by Radiochemotherapy * Advanced high grade epithelial ovarian cancer : treatment by 1st line Chemotherapy * Chronic Lymphocytic Leukemia (CLL) in the relapsed setting : treatment by Bruton Kinase Inhibitors I2. All solid tumor cohorts: Availability of an archival representative formalin-fixed paraffin-embedded (FFPE) tumor sample \[...\] I3. All solid tumor cohorts: Disease evaluable as per RECIST V1.1 I4. All solid tumor cohorts excluding Glioblastoma: Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic mandatory de novo tumor sampling \[...\] I5. Performance status (PS) ECOG 0 or 1. I6. Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures including sequential tumor biopsies as per protocol. I7. Patient must be covered by a medical insurance. Exclusion Criteria: NI1. All solid tumor cohorts - Patient with non-acceptable tumor sample at screening. NI2. Any condition contraindicated with blood/tumor sampling procedures required by the protocol. NI3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. NI4. Pregnant or breast-feeding woman.
Where this trial is running
Bron and 1 other locations
- HOPITAL Pierre WERTHEIMER - HCL — Bron, France (NOT_YET_RECRUITING)
- Centre Léon Bérard — Lyon, France (RECRUITING)
Study contacts
- Principal investigator: Pierre SAINTIGNY, MD, PhD — Centre Leon Berard
- Study coordinator: Pierre SAINTIGNY, MD, PhD
- Email: Pierre.saintigny@lyon.unicancer.fr
- Phone: 04 69 85 60 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic, Molecular Screening, Genomic profiles, Transcriptomic profiles