Analysis of Circulating Tumor Markers in the Blood (ALCINA) (ALCINA)
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ClinicalTrials.gov Identifier: NCT02866149 |
Recruitment Status :
Recruiting
First Posted : August 15, 2016
Last Update Posted : August 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Biological: Blood sampling Procedure: Tumor sampling Other: Stool sampling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 760 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Analysis of Circulating Tumor Markers in the Blood |
Actual Study Start Date : | July 2015 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2024 |
Arm | Intervention/treatment |
---|---|
Cohort 1 - "Anti checkpoint"
Monitoring of patients with tumours treated by immune therapy. Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 2 - "Oncoscan®"
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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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Experimental: Cohort 3 - "CirCe-PLA"
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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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points Procedure: Tumor sampling One tumor sampling can be performed, if applicable |
Cohort 4 - "CDX PDX"
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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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points Procedure: Tumor sampling One tumor sampling can be performed, if applicable |
Cohort 5 - "Post-TP53"
Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer. Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 6 - "Palbociclib"
Monitoring of patients treated with palbociclib Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 7 - "CTC_PD-L1_Breast"
Detection of PD-L1 in metastatic breast cancer patients Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary"
Detection of PD-L1 in metastatic lung cancer patients Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 9 - "NSCLC"
Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. |
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points Procedure: Tumor sampling One tumor sampling can be performed, if applicable Other: Stool sampling Up to 5 blood samplings can be performed at different time points |
Cohort 10 - "Palbociclib II"
Monitoring of patient with a metastatic breast cancer treated by palbociclib. Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 11 - Sarcomas
The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging.
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 12 - Faslorad
Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor. Timing of blood sampling:
|
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 13 - MUm
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:
|
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
Cohort 14 - CNBC Snipe
This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1. One tumour sampling. Timing of blood sampling:
|
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points Procedure: Tumor sampling One tumor sampling can be performed, if applicable |
Cohort 15 - Breast CLI
This cohort concerns patients with metastatic lobular breast cancer One tumour sampling. Timing of blood sampling:
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Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points Procedure: Tumor sampling One tumor sampling can be performed, if applicable |
Cohort 16 - Mum immunothérapie
This cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment. Timing of blood sampling :
|
Biological: Blood sampling
Up to 5 blood samplings can be performed at different time points |
- Feasibility of the analysis of different blood-borne tumor biomarkers [ Time Frame: 18 months ]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 ".
- Correlation with biological and clinical data [ Time Frame: 18 months ]Number of biological analysis results correlated to clinical data. Establishment of a proof of concept

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with any tumoral disease (proven or suspected), of any type and stage
- More than18 years old
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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
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866149
Contact: Anne-Sophie PLISSONNIER | anne-sophie.plissonnier@curie.fr | ||
Contact: François-Clément BIDARD, MD PhD | +33 144 324 682 | francois-clement.bidard@curie.fr |
France | |
Centre Georges François Leclerc | Not yet recruiting |
Dijon, France, 21079 | |
Principal Investigator: François GHIRINGHELLI, MD | |
Institut du Cancer de Montpellier | Recruiting |
Montpellier, France, 34298 | |
Contact: William JACOT, MD PhD William.Jacot@icm.unicancer.fr | |
Principal Investigator: William JACOT, MD PhD | |
Institut Curie (Paris hospital) | Recruiting |
Paris, France, 75005 | |
Contact: François-Clément BIDARD, MD PhD francois-clement.bidard@curie.fr | |
Principal Investigator: François-Clément BIDARD, MD PhD | |
Institut Mutualiste Montsouris | Not yet recruiting |
Paris, France, 75014 | |
Contact: Christophe LOUVET, MD PhD | |
Principal Investigator: Christophe LOUVET, MD PhD | |
Institut Curie (St Cloud hospital) | Recruiting |
Saint-cloud, France, 92210 | |
Contact: Jean-Yves PIERGA, MD PhD jean-yves.pierga@curie.fr | |
Principal Investigator: Jean-Yves PIERGA, MD PhD |
Study Director: | François-Clément BIDARD, MD PhD | Institut Curie, Paris (FR) |
Responsible Party: | Institut Curie |
ClinicalTrials.gov Identifier: | NCT02866149 |
Other Study ID Numbers: |
IC 2015-02 |
First Posted: | August 15, 2016 Key Record Dates |
Last Update Posted: | August 3, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Cancer circulating tumor biomarkers circulating tumor DNA Circulating tumor Cell (CTC) |