Analysis of Circulating Tumor Markers in Blood
NCT04025541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 992
Last updated 2025-04-02
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.
Conditions
Interventions
- BIOLOGICAL
-
Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
- BIOLOGICAL
-
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).
- BIOLOGICAL
-
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
- BIOLOGICAL
-
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)
- BIOLOGICAL
-
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).
- BIOLOGICAL
-
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
- BIOLOGICAL
-
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
- BIOLOGICAL
-
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
- BIOLOGICAL
-
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.
Sponsors & Collaborators
-
Institut du Cancer de Montpellier - Val d'Aurelle
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-29
- Primary Completion
- 2026-05-29
- Completion
- 2029-05-29
Countries
- France
Study Locations
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