Recruiting

ALCINA2Analysis of Circulating Tumor Markers in Blood

What is being tested

Blood sampling

+ Blood sampling C3

+ Blood sampling C4/7/10/13

Biological

Who is being recruted

Breast Diseases+26

+ Breast Neoplasms

+ Colonic Diseases

Over 18 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: May 2018

See protocol details

Summary

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Study Contacttexier emmannuelle

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 29, 2018

Actual date on which the first participant was enrolled.

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).

Official TitleAnalysis of Circulating Tumor Markers in Blood

NCT04025541

Principal SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Study Contacttexier emmannuelle

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

992 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsColonic DiseasesColonic NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsGliomaIntestinal DiseasesIntestinal NeoplasmsLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRespiratory Tract DiseasesRespiratory Tract NeoplasmsSarcomaSkin DiseasesThoracic NeoplasmsColorectal NeoplasmsSkin and Connective Tissue DiseasesNeuroectodermal TumorsNeoplasms, Connective and Soft TissueNeoplasms, Neuroepithelial

Criteria

3 inclusion criteria required to participate

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.

4 exclusion criteria prevent from participating

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,

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

13 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING

Group II

Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING

Group III

Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy

Group IV

Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma

Group 5

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Group 6

Patient with metastatic colorectal adenocarcinoma

Group 7

Patients with non-metastatic colon cancer

Group 8

Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd

Group 9

Patient with grade II, III or IV diffuse glioma

Group 10

Patients with treatment-naive metastatic breast cancer with distant metastases

Group 11

Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated.

Group 12

Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C

Group 13

Patient with breast cancer and suspected with leptomeningeal metastases

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

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

Montpellier, FranceOpen Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle in Google Maps

Recruiting

ICM

Montpellier, France

Recruiting

2 Study Centers