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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07060950

Analysis of Circulating Tumor Markers in Blood - ALCINA 5

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
620 (estimated)
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
BIOLOGICALBlood sampling C1Blood samples will be collected at four key time points : * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4).

Timeline

Start date
2025-10-01
Primary completion
2030-07-01
Completion
2035-07-01
First posted
2025-07-11
Last updated
2025-09-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07060950. Inclusion in this directory is not an endorsement.