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Analisi dei marcatori tumorali circolanti nel sangue (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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

992

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Montpellier, Francia, 34298
      • Montpellier, Francia, 34298
        • Reclutamento
        • ICM
        • Contatto:
          • WILLIAM JACOT

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
  2. Man or woman ≥ 18 years,
  3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion Criteria:

  1. Private persons of freedom or under guardianship,
  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,

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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

Altri nomi:
  • Campionamento tumorale
Altro: 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

Altri nomi:
  • Campionamento tumorale
Altro: COHORT 3 - LUNG CANCER

Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy

Blood samples will be collected at four key time points:

  • baseline (T1),
  • first scan assessment (T2),
  • second scan assessment (T3),
  • and progression (T4).
Altro: COHORT 4 - CCRm

Patient with metastatic colorectal adenocarcinoma

Blood samples will be collected before any treatment

Altro: 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:

  • 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)
Altro: COHORT 6 - Glioma

Patient with grade II, III or IV diffuse glioma

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).
Altro: COHORT 7 - CIRCUS 2

Patients with non-metastatic colon cancer

Blood samples will be collected before any treatment

Altro: 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:

  • At the inclusion
  • At follow-up visit 2 to 6, every 3 months
Altro: 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:

  • 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
Altro: 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

Altro: 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:

  • 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
Altro: COHORT 12 - LMD

Patient with breast cancer and suspected with leptomeningeal metastases

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.
Altro: COHORT 13 - RILA STAB

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Blood samples will be collected before any treatment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 4 years

Number of CTCs expressing PDL1 at T1

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
Lasso di tempo: 1 year

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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 4 years

Median number of CTCs 1 month after inclusion

4 years
COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique
Lasso di tempo: 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.
Lasso di tempo: 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
COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles
Lasso di tempo: 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)
Lasso di tempo: 4 years

Number of CTCs expressing HES 1 to T4

4 years
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).
Lasso di tempo: 4 years

Sensitivity of the hepcidin value in the 1st blood sample for the diagnosis of leptomeningeal metastases

4 years
COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 maggio 2018

Completamento primario (Stimato)

29 maggio 2029

Completamento dello studio (Stimato)

29 maggio 2032

Date di iscrizione allo studio

Primo inviato

5 giugno 2019

Primo inviato che soddisfa i criteri di controllo qualità

16 luglio 2019

Primo Inserito (Effettivo)

19 luglio 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .