Analysis of Circulating Tumor Markers in Blood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 992
- Locations
- 2
- Primary Endpoint
- Estimation of the feasibility of the various blood tumoral biomarkers analysis
Study Overview
Brief 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.
Detailed Description
The new major challenge in the research concerns the circulating biomarkers, which aim at replacing the molecular analyses on tumour tissue obtained by biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.
The study ALCINA 2 rests exactly on the principle of small cohorts, which correspond each to a clinical situation and/or a technique of different implemented detection, so as to generate data of feasibility and proof of concept. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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,
Arms & Interventions
COHORT 1 BREAST TUMOR/PALBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib
BLOOD SAMPLING
Intervention: Blood sampling (Biological)
COHORT 2 BREAST TUMOR / RIBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib
BLOOD SAMPLING
Intervention: Blood sampling (Biological)
COHORT 3 - LUNG CANCER
Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy
Intervention: Blood sampling C3 (Biological)
COHORT 4 - CCRm
Patient with metastatic colorectal adenocarcinoma
Intervention: Blood sampling C4/7/10/13 (Biological)
COHORT 5 - T-DXd
Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd
Intervention: Blood sampling C5 (Biological)
COHORT 6 - Glioma
Patient with grade II, III or IV diffuse glioma
Intervention: Blood sampling C6 (Biological)
COHORT 7 - CIRCUS 2
Patients with non-metastatic colon cancer
Intervention: Blood sampling C4/7/10/13 (Biological)
COHORT 8 - CTC-AXL Breast
Patients with treatment-naive metastatic breast cancer with distant metastases
Intervention: Blood sampling C8 (Biological)
COHORT 9 - ImmunoTNBC
Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated.
Intervention: Blood sampling C9 (Biological)
COHORT 10 - LPS
Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma
Intervention: Blood sampling C4/7/10/13 (Biological)
COHORT 11 - LUNG DRIVER
Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C
Intervention: Blood sampling C11 + FFPE (Biological)
COHORT 12 - LMD
Patient with breast cancer and suspected with leptomeningeal metastases
Intervention: Blood sampling C12 (Biological)
COHORT 13 - RILA STAB
Patients with breast cancer requiring radiotherapy, whatever the tumor stage
Intervention: Blood sampling C4/7/10/13 (Biological)
Outcomes
Primary Outcomes
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Time Frame: 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"
Secondary Outcomes
- COHORT 9 : to evaluate the predictive value of circulating immune populations for response to neo-adjuvant chemo-immunotherapy (according to pCR) in patients with early TNBCs, by performing an immunomonitoring before, during and after the treatment.(4 years)
- COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles(4 years)
- COHORT 11 : to demonstrate a correlation between tumour progression under targeted therapy against EGFR (DEL19; L858R), KRAS G12C and the number of CTCs expressing the HES 1 marker at progression (T4)(4 years)
- COHORT 12 : to assess the sensitivity of the hepcidin assay in blood for the diagnosis of leptomeningeal metastases of breast cancer, the gold standard being cytological examination of CSF (up to 3 samples).(4 years)
- COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)(1 year)
- COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related(4 YEARS)
- COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related(4 YEARS)
- 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)(4 years)
- COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer(1 year)
- COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment(4 years)
- COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence(4 years)
- COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)(4 years)
- COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique(4 years)