Analysis of Circulating Tumor Markers in Blood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
About this trial
The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
Man or woman ≥ 18 years,
Obtaining of the informed consent signed before any procedure of specific preselection on approval.
Disqualifiers
Private persons of freedom or under guardianship,
Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
Pregnant woman and/or breast-feeding,
Unaffiliated patient to Social Protection System,
Trial design
Design model
Parallel
Treatments tested in this trial
Blood sampling
Biological/Vaccineblood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Blood sampling C3
Biological/VaccineBlood samples will be collected at four key time points: * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4).
Blood sampling C4/7/10/13
Biological/VaccineBlood samples will be collected before any treatment
Blood sampling C5
Biological/VaccineBlood samples will be collected at four key time points: * At the inclusion (T1) * Before the beginning of the treatment (cycle 1 day 1) (T2) * After the first cycle of T-DXd (cycle 2 day 1) (T3) * At progression or at the end of the follow-up (after 3 years) (T4)
Blood sampling C6
Biological/VaccineBlood samples will be collected at three key time points: * At the inclusion (T1) * For patients starting treatment at the time of inclusion (T2): * Chemotherapy: 3 months after inclusion, * Concurrent chemoradiotherapy with Temozolomide: 4-6 weeks after completion of radiotherapy, * For patients starting treatment at the time of inclusion: at the time of tumor progression if occurring within one year of inclusion, or 12 months after inclusion in the absence of progression (T3).
Blood sampling C8
Biological/VaccineBlood samples will be collected at five key time points: * At the inclusion * At follow-up visit 2 to 6, every 3 months
Blood sampling C9
Biological/VaccineBlood samples will be collected at four key time points: * At the inclusion before the beginning of the treatment (Cycle 1 Day 1) * After the first cycle of the first chemo-immunotherapy sequence (Cycle 2 Day 1) * After the first cycle of the second chemotherapy sequence (Cycle 2b Day 1) * After the end of the whole neo-adjuvant chemo-immunotherapy protocol, before surgery
Blood sampling C11 + FFPE
Biological/VaccineBlood samples will be collected at five key time points: * At the inclusion (T1) * At first clinical evaluation (T2): 4th week after start of treatment * At first scan evaluation (T3a): 8th week after start of treatment * At the Nth scan evaluation (T3b, c, ...) * At progression (T4) Tumor sampling : * At the inclusion * At tumor progression
Blood sampling C12
Biological/VaccineBlood samples will be collected at several points : * Inclusion: at the time of suspected leptomeningeal metastases, prior to any specific treatment, * Every 4 weeks until meningeal progression, or for a maximum of 4 months, * Then every 3 months beyond 4 months until meningeal progression.
Treatment groups
992 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: COHORT 1 BREAST TUMOR/PALBOCICLIBOther 1 intervention
Group B: COHORT 2 BREAST TUMOR / RIBOCICLIBOther 1 intervention
Group C: COHORT 3 - LUNG CANCEROther 1 intervention
Group D: COHORT 4 - CCRmOther 1 intervention
Group E: COHORT 5 - T-DXdOther 1 intervention
Group F: COHORT 6 - GliomaOther 1 intervention
Group G: COHORT 7 - CIRCUS 2Other 1 intervention
Group H: COHORT 8 - CTC-AXL BreastOther 1 intervention
Group I: COHORT 9 - ImmunoTNBCOther 1 intervention
Group J: COHORT 10 - LPSOther 1 intervention
Group K: COHORT 11 - LUNG DRIVEROther 1 intervention
Group L: COHORT 12 - LMDOther 1 intervention
Group M: COHORT 13 - RILA STABOther 1 intervention
Trial outcomes
Primary outcomes
1
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients"
Time frame
4 YEARSSecondary outcomes
1
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03
Time frame
4 YEARS2
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03
Time frame
4 YEARS3
COHORT 3 : Correlation between response to immunotherapy (progressive versus non-progressive) and the number of circulating tumour cells (CTC) expressing the PDL1 marker at T1 (baseline)
Number of CTCs expressing PDL1 at T1
Time frame
4 years4
COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
Expression of the MS9 mRNA biomarker
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov