Analysis of Circulating Tumor Markers in Blood

NCT04025541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 992

Last updated 2025-04-02

No results posted yet for this 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.

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025541 on ClinicalTrials.gov