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NCT Number: NCT07060950

Analysis of Circulating Tumor Markers in Blood - ALCINA 5

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

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, 34298

Location contact

Aurore MOUSSION

CONTACT

[email protected]

467613102 ext. +33

Marc Ychou, MD, PhD

CONTACT

[email protected]

467613066 ext. +33

William JACOT, MD

PRINCIPAL_INVESTIGATOR

About this study

The new major challenge in research focuses on the rapid evaluation of circulating biomarker candidates, which could replace or complement molecular analyses of tumor tissue obtained through 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 5 relies exactly on the principle of small cohorts based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy. Which cohort correspond each to a clinical situation and/or a technique of different implemented detection. 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,
  • 18 years old or higher ?
  • Patient who has provided informed, written, and explicit consent,
  • Patient affiliated with a French Social Protection System.

In the case of a tumor biopsy:

  • Tumor considered as accessible by biopsy,
  • Normal hemostasis assessment (PT, APTT, platelets),
  • No anticoagulant or antiaggregant treatment for the biopsy.

Exclusion criteria

  • Pregnant woman and/or breast-feeding,
  • Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
  • Private persons of freedom or under guardianship,
  • Patient with a history of other invasive cancers within the 5 years preceding inclusion.

Treatment and study plan

Blood sampling C1

Biological

Blood samples will be collected at four key time points :

  • baseline (T1),
  • first scan assessment (T2),
  • second scan assessment (T3),
  • and progression (T4).

Primary outcomes

  1. All Cohorts : Study of the feasibility of detecting and/or analysing blood or tissue tumour biomarkers.

    Time frame: 10 years

    Success rate of the detection technique used (the criterion will be detailed according to the biomarker evaluated, in each of the cohorts)

Secondary outcomes

  1. COHORT 1 - CURE : to define a liquid biopsy signature for predicting therapeutic response from samples taken before initiation of immunotherapy (T1).

    Time frame: 4 years

    CTCs-PD-L1+/-, ctDNA, circulating proteins (CPs) and circulating immune cells (CICs) will be measured in accordance with the definitions established in T1.

Study contacts

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

Emmanuelle TEXIER

CONTACT

[email protected]

467613102 ext. +33

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Acronym: ALCINA 5

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Jul 11, 2025
Registry last updated
Sep 19, 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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