Analysis of Circulating Tumor Markers in Blood

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sampling: blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Blood sampling C3: Blood 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: Blood samples will be collected before any treatment

Blood sampling C5: Blood 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: Blood 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: Blood 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: Blood 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: Blood 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: Blood 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.

Study summary

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

Primary outcome measure(s)

• Estimation of the feasibility of the various blood tumoral biomarkers analysis — 4 YEARS
  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"

Trial sites (2)

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