RecruitingNot ApplicableNCT04025541

Analysis of Circulating Tumor Markers in Blood


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

992 participants

Start Date

May 29, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria4

  • 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,

Interventions

BIOLOGICALBlood sampling

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

BIOLOGICALBlood 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).

BIOLOGICALBlood sampling C4/7/10/13

Blood samples will be collected before any treatment

BIOLOGICALBlood 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)

BIOLOGICALBlood 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).

BIOLOGICALBlood 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

BIOLOGICALBlood 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

BIOLOGICALBlood 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

BIOLOGICALBlood 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.


Locations(2)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France

ICM

Montpellier, France

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NCT04025541


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