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NCT Number: NCT04025541

Analysis of Circulating Tumor Markers in Blood

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.

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Key information

Conditions

Cancer Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Glioma Intestinal Diseases Intestinal Neoplasms Lung Cancers Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Blood sampling

Biological

blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Other names: Tumor sampling

Blood sampling C3

Biological

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

Biological

Blood samples will be collected before any treatment

Blood sampling C5

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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

Biological

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.

Primary outcomes

  1. Estimation of the feasibility of the various blood tumoral biomarkers analysis

    Time frame: 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"

Secondary outcomes

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

    Time frame: 4 YEARS

    Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03

  2. COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related

    Time frame: 4 YEARS

    Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03

  3. 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)

    Time frame: 4 years

    Number of CTCs expressing PDL1 at T1

  4. COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer

    Time frame: 1 year

    Expression of the MS9 mRNA biomarker

  5. COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment

    Time frame: 4 years

    Progression-Free Survival (the primary outcome measure being the HR between CTC+ and CTC- patients, using the HER2+ CTC count at baseline)

  6. COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence

    Time frame: 4 years

    Positive predictive value and negative predictive value of the signature to discriminate glioma vs. no glioma

  7. COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)

    Time frame: 4 years

    Median number of CTCs 1 month after inclusion

  8. COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique

    Time frame: 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)

  9. 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.

    Time frame: 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.

  10. COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles

    Time frame: 4 years

    Sensibility and specificity of circulating MDM2 DNA in circulating vesicles for LPS diagnosis

  11. 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)

    Time frame: 4 years

    Number of CTCs expressing HES 1 to T4

  12. 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).

    Time frame: 4 years

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

  13. COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

texier emmannuelle

CONTACT

[email protected]

0467613102

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: ALCINA2

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Jul 19, 2019
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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