Analysis of Circulating Tumor Markers in the Blood (ALCINA)
NCT ID: NCT02866149
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
682 participants
INTERVENTIONAL
2015-07-31
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Analysis of Circulating Tumor Markers in Blood - ALCINA 5
NCT07060950
Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
NCT05088395
Analysis of Circulating Tumor Markers in Blood
NCT04025541
Research Into Biomarkers Predictive of Survival and Response to Cancer Treatment
NCT06851975
Studying Biomarkers in Tumor Tissue and Blood Samples From Patients With Small Cell Lung Cancer Registered on CALGB-140202
NCT01503619
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Each kind of blood-borne biological markers analyses corresponds to a cohort.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1 - "Anti checkpoint"
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.
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:
* inclusion
* after 1 cycle of therapy (weeks 3-4)
* up to 2 other samples, timepoints decided by the investigator
Blood sampling
Up to 5 blood samplings can be performed at different time points
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:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator.
Blood sampling
Up to 5 blood samplings can be performed at different time points
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:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator.
Blood sampling
Up to 5 blood samplings can be performed at different time points
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:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator.
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:
* Inclusion day (2 samples)
* after #2 weeks of therapy
* after #4 weeks of therapy
* at progression.
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:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator.
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:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator.
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.
Blood sampling
Up to 5 blood samplings can be performed at different time points
Tumor sampling
One tumor sampling can be performed, if applicable
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:
* Inclusion
* after #4 weeks of therapy
* at the first tumoral evaluation (month 3 or 4)
* at progression.
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.
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:
* Inclusion
* after #3-5 weeks of therapy
* at the first tumoral evaluation (month 2 or 3)
* at progression.
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:
* J1C1
* J2C1
* J1C2
* J1C5 (first tumoral evaluation).
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:
* before treatment
* at W8 of treatment (after radiological examination)
* at W12 of treatment
* at progression or 18 months after the beginning of treatment
Blood sampling
Up to 5 blood samplings can be performed at different time points
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:
* 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
Blood sampling
Up to 5 blood samplings can be performed at different time points
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 :
* at inclusion
* at cycle 2 or 3 of treatment
* at the first tumoral evaluation (C5D1)
* at progression
Blood sampling
Up to 5 blood samplings can be performed at different time points
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sampling
Up to 5 blood samplings can be performed at different time points
Tumor sampling
One tumor sampling can be performed, if applicable
Stool sampling
Up to 5 blood samplings can be performed at different time points
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. More than18 years old
3. Signed informed consent form
4. Tumor considered as accessible by biopsy
5. Normal blood coagulation tests on the last blood analysis
1. Patient in detention or protected by the law
2. Patient who cannot comply with the study follow up for geographical, social or psychological reasons
3. Anticoagulant or antiaggregant that cannot be interrupted for the biopsy
4. central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut Curie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
François-Clément BIDARD, MD PhD
Role: STUDY_DIRECTOR
Institut Curie, Paris (FR)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Georges François Leclerc
Dijon, , France
Institut du Cancer de Montpellier
Montpellier, , France
Institut Curie (Paris hospital)
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
Institut Curie (St Cloud hospital)
Saint-Cloud, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IC 2015-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.