Analysis of Circulating Tumor Markers in Blood - ALCINA 5

NCT07060950 | Not Yet Recruiting

• 1 other identifier: PROICM 2022-02 ALC
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Lung Cancer, Non-Small Cell

Outcome Measures

Primary Outcomes (1)

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

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

  10 years

Secondary Outcomes (1)

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

  4 years

Study Arms (1)

COHORT 1 - CURE

OTHER

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

Biological: Blood sampling C1

Interventions

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).

COHORT 1 - CURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

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

Montpellier, France, 34298, France

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Emmanuelle TEXIER

CONTACT

467613102; emmanuelle.texier@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional study (blood collections and possibly tumor sample collection depending on cohort type) on single group cohorts (each cohort is defined in the arms below).

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2035
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)