Analysis of Circulating Tumor Markers in Blood
ALCINA2
1 other identifier
interventional
992
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started May 2018
Longer than P75 for not_applicable cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2018
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2029
ExpectedApril 2, 2025
February 1, 2025
8 years
June 5, 2019
March 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
4 YEARS
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
4 YEARS
COHORT 3 : Correlation between response to immunotherapy (progressive versus non-progressive) and the number of circulating tumour cells (CTC) expressing the PDL1 marker at T1 (baseline)
4 years
COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
1 year
COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment
4 years
- +8 more secondary outcomes
Study Arms (13)
COHORT 1 BREAST TUMOR/PALBOCICLIB
OTHERPatient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING
COHORT 2 BREAST TUMOR / RIBOCICLIB
OTHERPatient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING
COHORT 3 - LUNG CANCER
OTHERPatients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy
COHORT 4 - CCRm
OTHERPatient with metastatic colorectal adenocarcinoma
COHORT 5 - T-DXd
OTHERPatient with HER2 + metastatic breast cancer, requiring treatment with T-DXd
COHORT 6 - Glioma
OTHERPatient with grade II, III or IV diffuse glioma
COHORT 7 - CIRCUS 2
OTHERPatients with non-metastatic colon cancer
COHORT 8 - CTC-AXL Breast
OTHERPatients with treatment-naive metastatic breast cancer with distant metastases
COHORT 9 - ImmunoTNBC
OTHERPatients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated.
COHORT 10 - LPS
OTHERPatients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma
COHORT 11 - LUNG DRIVER
OTHERPatients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C
COHORT 12 - LMD
OTHERPatient with breast cancer and suspected with leptomeningeal metastases
COHORT 13 - RILA STAB
OTHERPatients with breast cancer requiring radiotherapy, whatever the tumor stage
Interventions
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Blood samples will be collected at four key time points: * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4).
Blood samples will be collected before any treatment
Blood samples will be collected at four key time points: * At the inclusion (T1) * Before the beginning of the treatment (cycle 1 day 1) (T2) * After the first cycle of T-DXd (cycle 2 day 1) (T3) * At progression or at the end of the follow-up (after 3 years) (T4)
Blood samples will be collected at three key time points: * At the inclusion (T1) * For patients starting treatment at the time of inclusion (T2): * Chemotherapy: 3 months after inclusion, * Concurrent chemoradiotherapy with Temozolomide: 4-6 weeks after completion of radiotherapy, * For patients starting treatment at the time of inclusion: at the time of tumor progression if occurring within one year of inclusion, or 12 months after inclusion in the absence of progression (T3).
Blood samples will be collected at five key time points: * At the inclusion * At follow-up visit 2 to 6, every 3 months
Blood samples will be collected at four key time points: * At the inclusion before the beginning of the treatment (Cycle 1 Day 1) * After the first cycle of the first chemo-immunotherapy sequence (Cycle 2 Day 1) * After the first cycle of the second chemotherapy sequence (Cycle 2b Day 1) * After the end of the whole neo-adjuvant chemo-immunotherapy protocol, before surgery
Blood samples will be collected at five key time points: * At the inclusion (T1) * At first clinical evaluation (T2): 4th week after start of treatment * At first scan evaluation (T3a): 8th week after start of treatment * At the Nth scan evaluation (T3b, c, ...) * At progression (T4) Tumor sampling : * At the inclusion * At tumor progression
Blood samples will be collected at several points : * Inclusion: at the time of suspected leptomeningeal metastases, prior to any specific treatment, * Every 4 weeks until meningeal progression, or for a maximum of 4 months, * Then every 3 months beyond 4 months until meningeal progression.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298, France
ICM
Montpellier, 34298, France
Related Publications (4)
Bardol T, Eslami-S Z, Masmoudi D, Alexandre M, Duboys de Labarre M, Bobrie A, D'Hondt V, Guiu S, Kurma K, Cayrefourcq L, Jacot W, Alix-Panabieres C. First evidence of AXL expression on circulating tumor cells in metastatic breast cancer patients: A proof-of-concept study. Cancer Med. 2024 Jan;13(1):e6843. doi: 10.1002/cam4.6843. Epub 2023 Dec 22.
PMID: 38132919BACKGROUNDLeenhardt F, Fiteni F, Gauthier L, Alexandre M, Guiu S, Firmin N, Pouderoux S, Viala M, Lossaint G, Gautier C, Mollevi C, Gracia M, Gongora C, Mbatchi L, Evrard A, Jacot W. Pharmacokinetic Variability Drives Palbociclib-Induced Neutropenia in Metastatic Breast Cancer Patients: Drug-Drug Interactions Are the Usual Suspects. Pharmaceutics. 2022 Apr 11;14(4):841. doi: 10.3390/pharmaceutics14040841.
PMID: 35456675BACKGROUNDLeenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.
PMID: 34286354BACKGROUNDLeenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.
PMID: 32623316BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
July 19, 2019
Study Start
May 29, 2018
Primary Completion
May 29, 2026
Study Completion (Estimated)
May 29, 2029
Last Updated
April 2, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share