Analysis of Circulating Tumor Markers in Blood

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Analysis of Circulating Tumor Markers in Blood

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04025541
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer, Breast Cancer, Sarcoma, Lung Cancers, Glioma, Colon Cancer

Additional Details

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).

Arms & Interventions

Arms

Other: COHORT 1 BREAST TUMOR/PALBOCICLIB

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

Other: COHORT 2 BREAST TUMOR / RIBOCICLIB

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

Other: COHORT 3 - LUNG CANCER

Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy

Other: COHORT 4 - CCRm

Patient with metastatic colorectal adenocarcinoma

Other: COHORT 5 - T-DXd

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

Other: COHORT 6 - Glioma

Patient with grade II, III or IV diffuse glioma

Other: COHORT 7 - CIRCUS 2

Patients with non-metastatic colon cancer

Other: COHORT 8 - CTC-AXL Breast

Patients with treatment-naive metastatic breast cancer with distant metastases

Other: COHORT 9 - ImmunoTNBC

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

Other: COHORT 10 - LPS

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

Other: COHORT 11 - LUNG DRIVER

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

Other: COHORT 12 - LMD

Patient with breast cancer and suspected with leptomeningeal metastases

Other: COHORT 13 - RILA STAB

Patients with breast cancer requiring radiotherapy, whatever the tumor stage

Interventions

Biological: - Blood sampling

blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time

Biological: - Blood sampling C3

Blood samples will be collected at four key time points: - baseline (T1), - first scan assessment (T2), - second scan assessment (T3), - and progression (T4).

Biological: - Blood sampling C4/7/10/13

Blood samples will be collected before any treatment

Biological: - Blood sampling C5

Blood samples will be collected at four key time points: - At the inclusion (T1) - Before the beginning of the treatment (cycle 1 day 1) (T2) - After the first cycle of T-DXd (cycle 2 day 1) (T3) - At progression or at the end of the follow-up (after 3 years) (T4)

Biological: - Blood sampling C6

Blood samples will be collected at three key time points: - At the inclusion (T1) - For patients starting treatment at the time of inclusion (T2): - Chemotherapy: 3 months after inclusion, - Concurrent chemoradiotherapy with Temozolomide: 4-6 weeks after completion of radiotherapy, - For patients starting treatment at the time of inclusion: at the time of tumor progression if occurring within one year of inclusion, or 12 months after inclusion in the absence of progression (T3).

Biological: - Blood sampling C8

Blood samples will be collected at five key time points: - At the inclusion - At follow-up visit 2 to 6, every 3 months

Biological: - Blood sampling C9

Blood samples will be collected at four key time points: - At the inclusion before the beginning of the treatment (Cycle 1 Day 1) - After the first cycle of the first chemo-immunotherapy sequence (Cycle 2 Day 1) - After the first cycle of the second chemotherapy sequence (Cycle 2b Day 1) - After the end of the whole neo-adjuvant chemo-immunotherapy protocol, before surgery

Biological: - Blood sampling C11 + FFPE

Blood samples will be collected at five key time points: - At the inclusion (T1) - At first clinical evaluation (T2): 4th week after start of treatment - At first scan evaluation (T3a): 8th week after start of treatment - At the Nth scan evaluation (T3b, c, ...) - At progression (T4) Tumor sampling : - At the inclusion - At tumor progression

Biological: - Blood sampling C12

Blood samples will be collected at several points : - Inclusion: at the time of suspected leptomeningeal metastases, prior to any specific treatment, - Every 4 weeks until meningeal progression, or for a maximum of 4 months, - Then every 3 months beyond 4 months until meningeal progression.

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