Analysis of Circulating Tumor Markers in Blood (ALCINA2)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Enrolling

Conditions: Lung Cancers; Breast Cancer; Glioma; Sarcoma; Colon Cancer; Cancer

Treatments: Biological: Blood sampling; Biological: Blood sampling C9; Biological: Blood sampling C5; Biological: Blood sampling C11 + FFPE; Biological: Blood sampling C4/7/10/13; Biological: Blood sampling C6; Biological: Blood sampling C3; Biological: Blood sampling C12; Biological: Blood sampling C8

Study type: Interventional

Funder types: Other

Identifiers

NCT04025541

PROICM 2017-05 BAL

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 992 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,
2. Man or woman ≥ 18 years,
3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.

Exclusion criteria

1. Private persons of freedom or under guardianship,
2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,
3. Pregnant woman and/or breast-feeding,
4. Unaffiliated patient to Social Protection System,

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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992 participants in 13 patient groups

COHORT 1 BREAST TUMOR/PALBOCICLIB

Other group

Description:

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

Treatment:

Biological: Blood sampling

COHORT 2 BREAST TUMOR / RIBOCICLIB

Other group

Description:

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

Treatment:

Biological: Blood sampling

COHORT 3 - LUNG CANCER

Other group

Description:

Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy

Treatment:

Biological: Blood sampling C3

COHORT 4 - CCRm

Other group

Description:

Patient with metastatic colorectal adenocarcinoma

Treatment:

Biological: Blood sampling C4/7/10/13

COHORT 5 - T-DXd

Other group

Description:

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

Treatment:

Biological: Blood sampling C5

COHORT 6 - Glioma

Other group

Description:

Patient with grade II, III or IV diffuse glioma

Treatment:

Biological: Blood sampling C6

COHORT 7 - CIRCUS 2

Other group

Description:

Patients with non-metastatic colon cancer

Treatment:

Biological: Blood sampling C4/7/10/13

COHORT 8 - CTC-AXL Breast

Other group

Description:

Patients with treatment-naive metastatic breast cancer with distant metastases

Treatment:

Biological: Blood sampling C8

COHORT 9 - ImmunoTNBC

Other group

Description:

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

Treatment:

Biological: Blood sampling C9

COHORT 10 - LPS

Other group

Description:

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

Treatment:

Biological: Blood sampling C4/7/10/13

COHORT 11 - LUNG DRIVER

Other group

Description:

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

Treatment:

Biological: Blood sampling C11 + FFPE

COHORT 12 - LMD

Other group

Description:

Patient with breast cancer and suspected with leptomeningeal metastases

Treatment:

Biological: Blood sampling C12

COHORT 13 - RILA STAB

Other group

Description:

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Treatment:

Biological: Blood sampling C4/7/10/13