Analysis of Circulating Tumor Markers in Blood

Study Overview
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Brief Summary
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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
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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).

Official Title
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Analysis of Circulating Tumor Markers in Blood

Conditions
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Cancer

Intervention / Treatment
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* Biological: Blood sampling


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COHORT 1 BREAST TUMOR/PALBOCICLIB<br>Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING | Biological: Blood sampling<br>* blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time<br>* Other names: Tumor sampling;|
| Other: COHORT 2 BREAST TUMOR / RIBOCICLIB<br>Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING | Biological: Blood sampling<br>* blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time<br>* Other names: Tumor sampling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of the feasibility of the various blood tumoral biomarkers analysis | 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 | 4 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related | Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03 | 4 YEARS | 
| COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related | Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03 | 4 YEARS |