Analysis of Circulating Tumor Markers in Blood - ALCINA 5

NCT ID: NCT07060950

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2035-07-31

Brief 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

Cancer; Lung Cancer, Non-Small Cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COHORT 1 - CURE

Patients with histologically proven metastatic non-small cell lung carcinoma eligible for immunotherapy

Group Type: OTHER

Blood sampling C1

Intervention Type: BIOLOGICAL

Blood samples will be collected at four key time points :

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

Interventions

Blood sampling C1

Blood samples will be collected at four key time points :

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,

2. 18 years old or higher ?

3. Patient who has provided informed, written, and explicit consent,

4. Patient affiliated with a French Social Protection System.

In the case of a tumor biopsy:

5. Tumor considered as accessible by biopsy,

6. Normal hemostasis assessment (PT, APTT, platelets),

7. No anticoagulant or antiaggregant treatment for the biopsy.

Exclusion Criteria

1. Pregnant woman and/or breast-feeding,

2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,

3. Private persons of freedom or under guardianship,

4. Patient with a history of other invasive cancers within the 5 years preceding inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Montpellier, France, France

Countries

France

Central Contacts

Emmanuelle TEXIER

Role: CONTACT

emmanuelle.texier@icm.unicancer.fr

467613102 ext. +33

Facility Contacts

Marc Ychou, MD, PhD

Role: primary

marc.ychou@icm.unicancer.fr

467613066 ext. +33

Aurore MOUSSION

Role: backup

aurore.moussion@icm.unicancer.fr

467613102 ext. +33

Other Identifiers

PROICM 2022-02 ALC

Identifier Type: -

Identifier Source: org_study_id