- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04025541
Analýza cirkulujících nádorových markerů v krvi (ALCINA2)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
The new major challenge in the research concerns the circulating biomarkers, which aim at replacing the molecular analyses on tumour tissue obtained by biopsy (for example the search for somatic mutations of cancer) by a simple blood test (liquid biopsy). The other current important challenge is to have an idea of the interest to analyse the kinetics of blood markers, in particular in answer to a clinical "event", either through the chemotherapy, a biopsy and / or surgery. There is almost no data in the literature on this aspect. It is very likely that the liberation in the blood of the blood tumoral markers is strongly dependent on medical interventions on the tumour.
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).
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: texier emmannuelle
- Telefonní číslo: 0467613102
- E-mail: emmanuelle.texier@icm.unicancer.fr
Studijní místa
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Montpellier, Francie, 34298
- Nábor
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Kontakt:
- Marc Ychou, MD, PhD
- Telefonní číslo: 33-4-6761-3066
- E-mail: mychou@valdorel.fnclcc.fr
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Kontakt:
- Aurore MOUSSION
- Telefonní číslo: +33 0467613102
- E-mail: aurore.moussion@icm.unicancer.fr
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Montpellier, Francie, 34298
- Nábor
- ICM
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Kontakt:
- WILLIAM JACOT
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: COHORT 1 BREAST TUMOR/PALBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING |
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Ostatní jména:
|
|
Jiný: COHORT 2 BREAST TUMOR / RIBOCICLIB
Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING |
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Ostatní jména:
|
|
Jiný: COHORT 3 - LUNG CANCER
Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy |
Blood samples will be collected at four key time points:
|
|
Jiný: COHORT 4 - CCRm
Patient with metastatic colorectal adenocarcinoma |
Blood samples will be collected before any treatment |
|
Jiný: COHORT 5 - T-DXd
Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd |
Blood samples will be collected at four key time points:
|
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Jiný: COHORT 6 - Glioma
Patient with grade II, III or IV diffuse glioma |
Blood samples will be collected at three key time points:
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Jiný: COHORT 7 - CIRCUS 2
Patients with non-metastatic colon cancer |
Blood samples will be collected before any treatment |
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Jiný: COHORT 8 - CTC-AXL Breast
Patients with treatment-naive metastatic breast cancer with distant metastases |
Blood samples will be collected at five key time points:
|
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Jiný: COHORT 9 - ImmunoTNBC
Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated. |
Blood samples will be collected at four key time points:
|
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Jiný: COHORT 10 - LPS
Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma |
Blood samples will be collected before any treatment |
|
Jiný: COHORT 11 - LUNG DRIVER
Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C |
Blood samples will be collected at five key time points:
Tumor sampling :
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Jiný: COHORT 12 - LMD
Patient with breast cancer and suspected with leptomeningeal metastases |
Blood samples will be collected at several points :
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Jiný: COHORT 13 - RILA STAB
Patients with breast cancer requiring radiotherapy, whatever the tumor stage |
Blood samples will be collected before any treatment |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Estimation of the feasibility of the various blood tumoral biomarkers analysis
Časové okno: 4 YEARS
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Časové okno: 4 YEARS
|
Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03 |
4 YEARS
|
|
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Časové okno: 4 YEARS
|
Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03 |
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)
Časové okno: 4 years
|
Number of CTCs expressing PDL1 at T1 |
4 years
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COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
Časové okno: 1 year
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Expression of the MS9 mRNA biomarker |
1 year
|
|
COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment
Časové okno: 4 years
|
Progression-Free Survival (the primary outcome measure being the HR between CTC+ and CTC- patients, using the HER2+ CTC count at baseline) |
4 years
|
|
COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence
Časové okno: 4 years
|
Positive predictive value and negative predictive value of the signature to discriminate glioma vs. no glioma |
4 years
|
|
COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)
Časové okno: 4 years
|
Median number of CTCs 1 month after inclusion |
4 years
|
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COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique
Časové okno: 4 years
|
Concordance rate of CTC-AXL measurement (at inclusion) by EPIDROP technique (AXL(-): 0 vs AXL(+): ≥1) and CellSearch technique (AXL(-): 0 vs AXL(+): ≥1) |
4 years
|
|
COHORT 9 : to evaluate the predictive value of circulating immune populations for response to neo-adjuvant chemo-immunotherapy (according to pCR) in patients with early TNBCs, by performing an immunomonitoring before, during and after the treatment.
Časové okno: 4 years
|
Response to treatment is defined as a pathological complete response (i.e. no residual invasive tumor in breast and axillary lymph nodes (ypT0ypN0)) after neo-adjuvant therapy. |
4 years
|
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COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles
Časové okno: 4 years
|
Sensibility and specificity of circulating MDM2 DNA in circulating vesicles for LPS diagnosis |
4 years
|
|
COHORT 11 : to demonstrate a correlation between tumour progression under targeted therapy against EGFR (DEL19; L858R), KRAS G12C and the number of CTCs expressing the HES 1 marker at progression (T4)
Časové okno: 4 years
|
Number of CTCs expressing HES 1 to T4 |
4 years
|
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COHORT 12 : to assess the sensitivity of the hepcidin assay in blood for the diagnosis of leptomeningeal metastases of breast cancer, the gold standard being cytological examination of CSF (up to 3 samples).
Časové okno: 4 years
|
Sensitivity of the hepcidin value in the 1st blood sample for the diagnosis of leptomeningeal metastases |
4 years
|
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COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)
Časové okno: 1 year
|
The mean RILA at 24h (D1), 48h (D2), 72h (D3) and 96h (D4) will be compared. Equivalences between conditions ((1) 24h and 48h, (2) 24h and 72h, (3) 24h and 96h) will be assessed using Passing & Bablok regression and/or paired t-test. Also, linear regressions between 24h, 48h, 72h and 96h for the same patients will be evaluated in order to determine, if necessary, a conversion formula. |
1 year
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Leenhardt F, Jacot W, Lellouche L, Guiu S, Viala M, Firmin N, Payen A, Mbatchi LC, Fiteni F, Evrard A. Antacid co-treatment and pregnane X receptor genetic polymorphisms are survival determinants in patients treated with palbociclib. Breast Cancer Res Treat. 2026 Jul 28;218(2):20. doi: 10.1007/s10549-026-08041-0.
- Kurma K, Bardol T, Mollevi C, Eslami-S Z, Garima F, Alexandre M, Bobrie A, Lossaint G, Massemin B, D'Hondt V, Guiu S, Cayrefourcq L, Jacot W, Alix-Panabieres C. Liquid biopsy reveals the immune status and protein profiles linked to CTC burden and clinical outcomes in metastatic breast cancer. J Exp Clin Cancer Res. 2026 Apr 18;45(1):111. doi: 10.1186/s13046-026-03709-3.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary podle místa
- Střevní nemoci
- Nemoci dýchacích cest
- Novotvary podle histologického typu
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Kolorektální novotvary
- Střevní novotvary
- Plicní onemocnění
- Novotvary, žlázové a epiteliální
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Onemocnění tlustého střeva
- Kožní choroby
- Nemoci prsu
- Novotvary, neuroepiteliální
- Neuroektodermální nádory
- Novotvary, zárodečné buňky a embryonální
- Novotvary, nervová tkáň
- Novotvary, pojivové a měkké tkáně
- Onemocnění kůže a pojivové tkáně
- Novotvary
- Novotvary plic
- Novotvary tlustého střeva
- Novotvary prsu
- Gliom
- Sarkom
- Vyšetřovací techniky
- Manipulace se vzorkem
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Vpichy
- Chirurgické postupy, operativní
- Sběr vzorků krve
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