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Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - "Anti checkpoint" | Other | Monitoring of patients with tumours treated by immune therapy. Timing of blood sampling:
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| Cohort 2 - "Oncoscan®" | Other | 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:
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| Cohort 3 - "CirCe-PLA" | Experimental | 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:
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| Cohort 4 - "CDX PDX" | Other | Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling. One tumor sampling. Timing of blood sampling:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Up to 5 blood samplings can be performed at different time points |
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| 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 |
| 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 |
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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)
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| Name | Affiliation | Role |
|---|---|---|
| François-Clément BIDARD, MD PhD | Institut Curie, Paris (FR) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21079 | France | |||
| Institut du Cancer de Montpellier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42082165 | Derived | Rampanou A, Rodrigues M, Bidard FC, Cassoux N, Matet A, Vincent-Salomon A, Jeannot E, Bieche I, Roman-Roman S, Stern MH, Renault S. Circulating Tumor DNA Monitoring in Patients with Uveal Melanoma Using Mutation-Agnostic Multiplex Drop-Off ddPCR Assays. Anal Chem. 2026 May 19;98(19):14260-14269. doi: 10.1021/acs.analchem.6c00476. Epub 2026 May 4. | |
| 39402032 |
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Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Cohort 5 - "Post-TP53" | Other | Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer. Timing of blood sampling:
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| Cohort 6 - "Palbociclib" | Other | Monitoring of patients treated with palbociclib Timing of blood sampling:
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| Cohort 7 - "CTC_PD-L1_Breast" | Other | Detection of PD-L1 in metastatic breast cancer patients Timing of blood sampling:
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| Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary" | Other | Detection of PD-L1 in metastatic lung cancer patients Timing of blood sampling:
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| Cohort 9 - "NSCLC" | Other | Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. |
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| Cohort 10 - "Palbociclib II" | Other | Monitoring of patient with a metastatic breast cancer treated by palbociclib. Timing of blood sampling:
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| Cohort 11 - Sarcomas | Other | The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging. |
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| Cohort 12 - Faslorad | Other | Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor. Timing of blood sampling:
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| Cohort 13 - MUm | Other | 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:
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| Cohort 14 - CNBC Snipe | Other | This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1. One tumour sampling. Timing of blood sampling:
|
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| Cohort 15 - Breast CLI | Other | This cohort concerns patients with metastatic lobular breast cancer One tumour sampling. Timing of blood sampling:
|
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| Cohort 16 - Mum immunothérapie | Other | This cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment. Timing of blood sampling :
|
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| Tumor sampling | Procedure | One tumor sampling can be performed, if applicable |
|
| Stool sampling | Other | Up to 5 blood samplings can be performed at different time points |
|
| Montpellier |
| 34298 |
| France |
| Institut Curie (Paris hospital) | Paris | 75005 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Institut Curie (St Cloud hospital) | Saint-Cloud | 92210 | France |
| Rodrigues M, Ramtohul T, Rampanou A, Sandoval JL, Houy A, Servois V, Mailly-Giacchetti L, Pierron G, Vincent-Salomon A, Cassoux N, Mariani P, Dutriaux C, Pracht M, Ryckewaert T, Kurtz JE, Roman-Roman S, Piperno-Neumann S, Bidard FC, Stern MH, Renault S. Prospective assessment of circulating tumor DNA in patients with metastatic uveal melanoma treated with tebentafusp. Nat Commun. 2024 Oct 14;15(1):8851. doi: 10.1038/s41467-024-53145-0. |
| 37973956 | Derived | Eslami-S Z, Cortes-Hernandez LE, Sinoquet L, Gauthier L, Vautrot V, Cayrefourcq L, Avoscan L, Jacot W, Pouderoux S, Viala M, Thomas QD, Lamy PJ, Quantin X, Gobbo J, Alix-Panabieres C. Circulating tumour cells and PD-L1-positive small extracellular vesicles: the liquid biopsy combination for prognostic information in patients with metastatic non-small cell lung cancer. Br J Cancer. 2024 Jan;130(1):63-72. doi: 10.1038/s41416-023-02491-9. Epub 2023 Nov 16. |
| 34355741 | Derived | Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabieres C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131. |
| 33676547 | Derived | Darrigues L, Pierga JY, Bernard-Tessier A, Bieche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0. |
| 32928264 | Derived | Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2. |
| 32712650 | Derived | Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabieres C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |