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
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RECRUITING
NA
992 participants
INTERVENTIONAL
2018-05-29
2029-05-29
Brief Summary
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Detailed Description
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The study ALCINA 2 rests exactly on the principle of small cohorts, which correspond each to a clinical situation and/or a technique of different implemented detection, so as to generate data of feasibility and proof of concept. In case of success, statistical hypotheses will be necessary for the implementation of wider studies (being then the object of a specific approval by competent authorities).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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COHORT 1 BREAST TUMOR/PALBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib
BLOOD SAMPLING
Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
COHORT 2 BREAST TUMOR / RIBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib
BLOOD SAMPLING
Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
COHORT 3 - LUNG CANCER
Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy
Blood sampling C3
Blood samples will be collected at four key time points:
* baseline (T1),
* first scan assessment (T2),
* second scan assessment (T3),
* and progression (T4).
COHORT 4 - CCRm
Patient with metastatic colorectal adenocarcinoma
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
COHORT 5 - T-DXd
Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd
Blood sampling C5
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)
COHORT 6 - Glioma
Patient with grade II, III or IV diffuse glioma
Blood sampling C6
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).
COHORT 7 - CIRCUS 2
Patients with non-metastatic colon cancer
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
COHORT 8 - CTC-AXL Breast
Patients with treatment-naive metastatic breast cancer with distant metastases
Blood sampling C8
Blood samples will be collected at five key time points:
* At the inclusion
* At follow-up visit 2 to 6, every 3 months
COHORT 9 - ImmunoTNBC
Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated.
Blood sampling C9
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
COHORT 10 - LPS
Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
COHORT 11 - LUNG DRIVER
Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C
Blood sampling C11 + FFPE
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
COHORT 12 - LMD
Patient with breast cancer and suspected with leptomeningeal metastases
Blood sampling C12
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.
COHORT 13 - RILA STAB
Patients with breast cancer requiring radiotherapy, whatever the tumor stage
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
Interventions
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Blood sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Blood sampling C3
Blood samples will be collected at four key time points:
* baseline (T1),
* first scan assessment (T2),
* second scan assessment (T3),
* and progression (T4).
Blood sampling C4/7/10/13
Blood samples will be collected before any treatment
Blood sampling C5
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 sampling C6
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 sampling C8
Blood samples will be collected at five key time points:
* At the inclusion
* At follow-up visit 2 to 6, every 3 months
Blood sampling C9
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 sampling C11 + FFPE
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 sampling C12
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Man or woman ≥ 18 years,
3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.
Exclusion Criteria
2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
3. Pregnant woman and/or breast-feeding,
4. Unaffiliated patient to Social Protection System,
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Locations
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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
ICM
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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WILLIAM JACOT
Role: primary
References
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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.
Leenhardt 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.
Leenhardt 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.
Leenhardt 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.
Other Identifiers
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PROICM 2017-05 BAL
Identifier Type: -
Identifier Source: org_study_id
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