Analysis of Circulating Tumor Markers in the Blood (ALCINA)

Study Overview
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Brief Summary
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Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

Detailed Description
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Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types). Each kind of blood-borne biological markers analyses corresponds to a cohort.

Official Title
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Analysis of Circulating Tumor Markers in the Blood

Conditions
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Cancer

Intervention / Treatment
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* Biological: Blood sampling
* Procedure: Tumor sampling
* Other: Stool sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with any tumoral disease (proven or suspected), of any type and stage More than18 years old Signed informed consent form Additional inclusion criteria if a tumor sample is needed: Tumor considered as accessible by biopsy Normal blood coagulation tests on the last blood analysis Non-inclusion Criteria: Patient in detention or protected by the law Patient who cannot comply with the study follow up for geographical, social or psychological reasons Additional non-inclusion criteria if a tumor sample is needed: Anticoagulant or antiaggregant that cannot be interrupted for the biopsy central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)

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 - Anti checkpoint<br>Monitoring of patients with tumours treated by immune therapy. Timing of blood sampling: inclusion after #8 weeks on therapy at progression or 6 months from inclusion for patient without progressive disease if toxicity grade 3 or 4, or grade 2 until 1 month. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 2 - Oncoscan®<br>Monitoring of patients with HER 2+/- breast cancer and correlation with genome-wide copy number, loss of heterozygosity detection, as well as identification of frequently tested somatic mutations (Oncoscan® assays). Timing of blood sampling: inclusion after 1 cycle of therapy (weeks 3-4) up to 2 other samples, timepoints decided by the investigator | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Experimental: Cohort 3 - CirCe-PLA<br>Feasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-). One tumor sampling. Timing of blood sampling: Inclusion up to 3 other samples, timepoints decided by the investigator. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>Procedure: Tumor sampling<br>* One tumor sampling can be performed, if applicable<br>|
| Other: Cohort 4 - CDX PDX<br>Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling. One tumor sampling. Timing of blood sampling: Inclusion up to 3 other samples, timepoints decided by the investigator. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>Procedure: Tumor sampling<br>* One tumor sampling can be performed, if applicable<br>|
| Other: Cohort 5 - Post-TP53<br>Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer. Timing of blood sampling: Inclusion up to 3 other samples, timepoints decided by the investigator. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 6 - Palbociclib<br>Monitoring of patients treated with palbociclib Timing of blood sampling: Inclusion day (2 samples) after #2 weeks of therapy after #4 weeks of therapy at progression. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 7 - CTC_PD-L1_Breast<br>Detection of PD-L1 in metastatic breast cancer patients Timing of blood sampling: Inclusion up to 3 other samples, timepoints decided by the investigator. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 8 - CTC_PD-L1_Broncho-Pulmonary<br>Detection of PD-L1 in metastatic lung cancer patients Timing of blood sampling: Inclusion up to 3 other samples, timepoints decided by the investigator. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 9 - NSCLC<br>Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>Procedure: Tumor sampling<br>* One tumor sampling can be performed, if applicable<br>Other: Stool sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 10 - Palbociclib II<br>Monitoring of patient with a metastatic breast cancer treated by palbociclib. Timing of blood sampling: Inclusion after #4 weeks of therapy at the first tumoral evaluation (month 3 or 4) at progression. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 11 - Sarcomas<br>The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 12 - Faslorad<br>Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor. Timing of blood sampling: Inclusion after #3-5 weeks of therapy at the first tumoral evaluation (month 2 or 3) at progression. | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 13 - MUm<br>The cohort concerns patients with uveal melanoma in the 1st systemic line at the metastatic stage (may have had prior adjuvant therapy or surgery/radiofrequency). Timing of blood sampling: J1C1 J2C1 J1C2 J1C5 (first tumoral evaluation). | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|
| Other: Cohort 14 - CNBC Snipe<br>This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1. One tumour sampling. Timing of blood sampling: before treatment at W8 of treatment (after radiological examination) at W12 of treatment at progression or 18 months after the beginning of treatment | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>Procedure: Tumor sampling<br>* One tumor sampling can be performed, if applicable<br>|
| Other: Cohort 15 - Breast CLI<br>This cohort concerns patients with metastatic lobular breast cancer One tumour sampling. Timing of blood sampling: At inclusion After biopsy post inclusion (or in 15 days after) after 1 or 2 months of treatment at progression or 18 months after inclusion | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>Procedure: Tumor sampling<br>* One tumor sampling can be performed, if applicable<br>|
| Other: Cohort 16 - Mum immunothérapie<br>This cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment. Timing of blood sampling : at inclusion at cycle 2 or 3 of treatment at the first tumoral evaluation (C5D1) at progression | Biological: Blood sampling<br>* Up to 5 blood samplings can be performed at different time points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the analysis of different blood-borne tumor biomarkers | 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 . | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with biological and clinical data | Number of biological analysis results correlated to clinical data. Establishment of a proof of concept | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, circulating tumor biomarkers, circulating tumor DNA, Circulating tumor Cell (CTC)