Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Analyse av sirkulerende tumormarkører i blod (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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

992

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Montpellier, Frankrike, 34298
      • Montpellier, Frankrike, 34298
        • Rekruttering
        • ICM
        • Ta kontakt med:
          • WILLIAM JACOT

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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,

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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

Andre navn:
  • Tumorprøvetaking
Annen: 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

Andre navn:
  • Tumorprøvetaking
Annen: 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).
Annen: COHORT 4 - CCRm

Patient with metastatic colorectal adenocarcinoma

Blood samples will be collected before any treatment

Annen: 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)
Annen: 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).
Annen: COHORT 7 - CIRCUS 2

Patients with non-metastatic colon cancer

Blood samples will be collected before any treatment

Annen: 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
Annen: 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
Annen: 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

Annen: 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
Annen: 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.
Annen: COHORT 13 - RILA STAB

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Blood samples will be collected before any treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. mai 2018

Primær fullføring (Antatt)

29. mai 2029

Studiet fullført (Antatt)

29. mai 2032

Datoer for studieregistrering

Først innsendt

5. juni 2019

Først innsendt som oppfylte QC-kriteriene

16. juli 2019

Først lagt ut (Faktiske)

19. juli 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .