An interventional study of Blood and tumor samples in Advanced / Metastic Solid Tumors, Glioblastoma and Chronic Leukemia Lymphocytic, sponsored by Centre Leon Berard. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Diagnostic
The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.
Most of the molecular screening programs have allowed to successfully guide patients to personalized therapy only for a minority of patients (10-20%) and few patients have actually benefit from these programs with low objective response under personalized therapy.
During the course of disease and / or of treatment, tumors become more heterogeneous and include a collection of cells harboring distinct molecular signatures with differential levels of sensitivity to treatment. Assessment of tumor heterogeneity and plasticity are essential for the development of effective therapies. Longitudinal analysis of biopsy samples is of considerable interest to assess the complex clonal architecture of cancers and potentially adapt cancer treatment to tumor profile/characteristics overtime. In this context, profiling of circulating tumor DNA using non-invasive liquid biopsies is also an interesting approach to assess cancer evolution by showing the contribution of clonal heterogeneity to chemotherapy resistance and metastasis in high-risk patients.
The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 500 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
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I1. Adult male or female patient with confirmed diagnosis of advanced/metastatic cancer to be treated with standard anti-cancer treatment according to :
Lung (V600E only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib): treatment by Dabrafenib + trametinib CRC (BRAF V600E): treatment by Encorafenib + cetuximab
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.
This cohort include following cancers treated with immunotherapy : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); MSI-High, any tumor types and HPV-related cancers,any tumor types
Biological: Blood and tumor samples
This cohort include following cancers treated with targeted therapies : Metastatic GIST; BRAF-mutated tumors (CRC (BRAF V600E), lung (V600 only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib) cancer); All solid tumor types with RET fusion / mutation and Chronic Lymphocytic Leukemia (CLL) in the relapsed setting.
Biological: Blood and tumor samples
This cohort include following cancers treated with chemotherapies : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); Metastatic Triple negative breast cancer (TNBC); Glioblastoma; Advanced high grade epithelial ovarian cancer
Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
Number of patients with meaningful molecular genetic alterations on tumor sample
Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of tumor at diagnosis, then under standard anti-cancer treatment : treatment start, 1st radiological evaluation and disease progression
Time frame: At the end of study (4 years)
Number of patients with meaningful molecular genetic alterations on circulating tumour DNA (ctDNA)
Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of ctDNA under standard anti-cancer treatment : treatment start, each radiological evaluation and disease progression
Time frame: At the end of study (4 years)
Number of patients with meaningful immunological features
Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment
Time frame: At the end of study (4 years)
Objective Response Rate (ORR) as per RECIST V1.1 and according to central review
For solid tumors excluding glioblastoma only
Time frame: 3 months
Progression-Free Survival (PFS)
For glioblastoma only
Time frame: 6 months
Objective Response Rate (ORR) according to iwCLL criteria
For chronic lymphocytic leukemia
Time frame: 6 months
Correlation between disease evolution and molecular and/or immunological biomarkers
To identify potential prognostic and predictive biomarkers on tumor samples collected during patient's treatment and follow-up detected by molecular biology techniques, and on immunological findings
Time frame: Time Frame: up to 4 years
Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.
To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques
Time frame: 48 months
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Time frame: 48 months
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
Time frame: 48 months
FACT-G questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time frame: 48 months
HADS questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time frame: 48 months
PRO questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time frame: 48 months
Correlation between patient's understanding and experiences of precision medicine clinical trial
Measured by thematic analysis of semi-structured interviews: themes and sub-themes will be analyzed in order to develop items for the construction and validation of a quantitative questionnaire.
Time frame: 48 months
Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients
Questionnaire
Time frame: 48 months
TKI pharmacokinetics
Plasma concentrations of TKI
Time frame: 48 months
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