CancerALCINA2NCT04025541
Analysis of Circulating Tumor Markers in Blood
A study testing Blood sampling, Blood sampling C3 and Blood sampling C4/7/10/13 in people with Cancer and Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Breast Cancer, Sarcoma
- What is being tested?
- Blood sampling, Blood sampling C3 and Blood sampling C4/7/10/13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 2 sitesFrance
- Study dates
- 29 May 2018to 29 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Marc Ychou, MD, PhD, 33-4-6761-3066, mychou@valdorel.fnclcc.fr
Aurore MOUSSION, 0467613102 ext. +33, aurore.moussion@icm.unicancer.fr
- Recruiting
ICM
Montpellier, 34298
WILLIAM JACOT
About this study
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.
Read the detailed 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).
- Conditions
- Cancer, Breast Cancer, Sarcoma, Lung Cancers, Glioma, Colon Cancer
- Being tested
- Blood sampling, Blood sampling C3, Blood sampling C4/7/10/13, Blood sampling C5, Blood sampling C6
- Medical subject headings
- Neoplasms, Breast Neoplasms, Sarcoma, Lung Neoplasms, Glioma, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Also called Tumor sampling
blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
Blood sampling C3Biological
Blood samples will be collected at four key time points:
- baseline (T1),
- first scan assessment (T2),
- second scan assessment (T3),
- and progression (T4).
Blood sampling C4/7/10/13Biological
Blood samples will be collected before any treatment
Blood sampling C5Biological
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)
Blood sampling C6Biological
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).
Blood sampling C8Biological
Blood samples will be collected at five key time points:
- At the inclusion
- At follow-up visit 2 to 6, every 3 months
Blood sampling C9Biological
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
Blood sampling C11 + FFPEBiological
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
Blood sampling C12Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| COHORT 1 BREAST TUMOR/PALBOCICLIB | Other | Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib
BLOOD SAMPLING Receives: Biological: Blood sampling |
| COHORT 2 BREAST TUMOR / RIBOCICLIB | Other | Patient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib
BLOOD SAMPLING Receives: Biological: Blood sampling |
| COHORT 3 - LUNG CANCER | Other | Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy Receives: Biological: Blood sampling C3 |
| COHORT 4 - CCRm | Other | Patient with metastatic colorectal adenocarcinoma Receives: Biological: Blood sampling C4/7/10/13 |
| COHORT 5 - T-DXd | Other | Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd Receives: Biological: Blood sampling C5 |
| COHORT 6 - Glioma | Other | Patient with grade II, III or IV diffuse glioma Receives: Biological: Blood sampling C6 |
| COHORT 7 - CIRCUS 2 | Other | Patients with non-metastatic colon cancer Receives: Biological: Blood sampling C4/7/10/13 |
| COHORT 8 - CTC-AXL Breast | Other | Patients with treatment-naive metastatic breast cancer with distant metastases Receives: Biological: Blood sampling C8 |
| COHORT 9 - ImmunoTNBC | Other | Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated. Receives: Biological: Blood sampling C9 |
| COHORT 10 - LPS | Other | Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma Receives: Biological: Blood sampling C4/7/10/13 |
| COHORT 11 - LUNG DRIVER | Other | Patients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C Receives: Biological: Blood sampling C11 + FFPE |
| COHORT 12 - LMD | Other | Patient with breast cancer and suspected with leptomeningeal metastases Receives: Biological: Blood sampling C12 |
| COHORT 13 - RILA STAB | Other | Patients with breast cancer requiring radiotherapy, whatever the tumor stage Receives: Biological: Blood sampling C4/7/10/13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients"
Measured: 4 YEARS
Secondary outcomes (13)
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Number of participants with treatment-related neutropenia as assessed by CTCAE v4.03
Measured: 4 YEARS
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Number of participants with treatment-related hepatic toxicity as assessed by CTCAE v4.03
Measured: 4 YEARS
COHORT 3 : Correlation between response to immunotherapy (progressive versus non-progressive) and the number of circulating tumour cells (CTC) expressing the PDL1 marker at T1 (baseline)
Number of CTCs expressing PDL1 at T1
Measured: 4 years
COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
Expression of the MS9 mRNA biomarker
Measured: 1 year
COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment
Progression-Free Survival (the primary outcome measure being the HR between CTC+ and CTC- patients, using the HER2+ CTC count at baseline)
Measured: 4 years
COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence
Positive predictive value and negative predictive value of the signature to discriminate glioma vs. no glioma
Measured: 4 years
COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)
Median number of CTCs 1 month after inclusion
Measured: 4 years
COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique
Concordance rate of CTC-AXL measurement (at inclusion) by EPIDROP technique (AXL(-): 0 vs AXL(+): ≥1) and CellSearch technique (AXL(-): 0 vs AXL(+): ≥1)
Measured: 4 years
COHORT 9 : to evaluate the predictive value of circulating immune populations for response to neo-adjuvant chemo-immunotherapy (according to pCR) in patients with early TNBCs, by performing an immunomonitoring before, during and after the treatment.
Response to treatment is defined as a pathological complete response (i.e. no residual invasive tumor in breast and axillary lymph nodes (ypT0ypN0)) after neo-adjuvant therapy.
Measured: 4 years
COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles
Sensibility and specificity of circulating MDM2 DNA in circulating vesicles for LPS diagnosis
Measured: 4 years
COHORT 11 : to demonstrate a correlation between tumour progression under targeted therapy against EGFR (DEL19; L858R), KRAS G12C and the number of CTCs expressing the HES 1 marker at progression (T4)
Number of CTCs expressing HES 1 to T4
Measured: 4 years
COHORT 12 : to assess the sensitivity of the hepcidin assay in blood for the diagnosis of leptomeningeal metastases of breast cancer, the gold standard being cytological examination of CSF (up to 3 samples).
Sensitivity of the hepcidin value in the 1st blood sample for the diagnosis of leptomeningeal metastases
Measured: 4 years
COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)
The mean RILA at 24h (D1), 48h (D2), 72h (D3) and 96h (D4) will be compared. Equivalences between conditions ((1) 24h and 48h, (2) 24h and 72h, (3) 24h and 96h) will be assessed using Passing \& Bablok regression and/or paired t-test. Also, linear regressions between 24h, 48h, 72h and 96h for the same patients will be evaluated in order to determine, if necessary, a conversion formula.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start29 May 2018
- Primary completion29 May 2026 (estimated)
- Study completion29 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 992 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025541
- Sponsor's protocol ID
- PROICM 2017-05 BAL
- Acronym
- ALCINA2
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bardol T, Eslami-S Z, Masmoudi D, Alexandre M, Duboys de Labarre M, Bobrie A, D'Hondt V, Guiu S, Kurma K, Cayrefourcq L, Jacot W, Alix-Panabieres C. First evidence of AXL expression on circulating tumor cells in metastatic breast cancer patients: A proof-of-concept study. Cancer Med. 2024 Jan;13(1):e6843. doi: 10.1002/cam4.6843. Epub 2023 Dec 22.
PubMed 38132919Leenhardt F, Fiteni F, Gauthier L, Alexandre M, Guiu S, Firmin N, Pouderoux S, Viala M, Lossaint G, Gautier C, Mollevi C, Gracia M, Gongora C, Mbatchi L, Evrard A, Jacot W. Pharmacokinetic Variability Drives Palbociclib-Induced Neutropenia in Metastatic Breast Cancer Patients: Drug-Drug Interactions Are the Usual Suspects. Pharmaceutics. 2022 Apr 11;14(4):841. doi: 10.3390/pharmaceutics14040841.
PubMed 35456675Leenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.
PubMed 34286354Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.
PubMed 32623316Leenhardt F, Jacot W, Lellouche L, Guiu S, Viala M, Firmin N, Payen A, Mbatchi LC, Fiteni F, Evrard A. Antacid co-treatment and pregnane X receptor genetic polymorphisms are survival determinants in patients treated with palbociclib. Breast Cancer Res Treat. 2026 Jul 28;218(2):20. doi: 10.1007/s10549-026-08041-0.
PubMed 42521839Kurma K, Bardol T, Mollevi C, Eslami-S Z, Garima F, Alexandre M, Bobrie A, Lossaint G, Massemin B, D'Hondt V, Guiu S, Cayrefourcq L, Jacot W, Alix-Panabieres C. Liquid biopsy reveals the immune status and protein profiles linked to CTC burden and clinical outcomes in metastatic breast cancer. J Exp Clin Cancer Res. 2026 Apr 18;45(1):111. doi: 10.1186/s13046-026-03709-3.
PubMed 42001180
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Tumor Markers in Blood
- ClinicalTrials.gov ID
- NCT04025541
- Acronym / sponsor ID
- ALCINA2 / PROICM 2017-05 BAL
- Conditions
- Cancer, Breast Cancer, Sarcoma, Lung Cancers, Glioma, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 992 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 29 May 2029 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| COHORT 1 BREAST TUMOR/PALBOCICLIB | Other | Biological: Blood samplingPatient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by palbociclib BLOOD SAMPLING |
| COHORT 2 BREAST TUMOR / RIBOCICLIB | Other | Biological: Blood samplingPatient with a locally Advanced tumor or metastatic tumor RH+/HER 2 - , treated by ribociclib BLOOD SAMPLING |
| COHORT 3 - LUNG CANCER | Other | Biological: Blood sampling C3Patients with histologically proven metastatic bronchial carcinoma eligible for immunotherapy |
| COHORT 4 - CCRm | Other | Biological: Blood sampling C4/7/10/13Patient with metastatic colorectal adenocarcinoma |
| COHORT 5 - T-DXd | Other | Biological: Blood sampling C5Patient with HER2 + metastatic breast cancer, requiring treatment with T-DXd |
| COHORT 6 - Glioma | Other | Biological: Blood sampling C6Patient with grade II, III or IV diffuse glioma |
| COHORT 7 - CIRCUS 2 | Other | Biological: Blood sampling C4/7/10/13Patients with non-metastatic colon cancer |
| COHORT 8 - CTC-AXL Breast | Other | Biological: Blood sampling C8Patients with treatment-naive metastatic breast cancer with distant metastases |
| COHORT 9 - ImmunoTNBC | Other | Biological: Blood sampling C9Patients newly diagnosed with non-metastatic stage II - III early TNBC, requiring neoadjuvant treatment and previously untreated. |
| COHORT 10 - LPS | Other | Biological: Blood sampling C4/7/10/13Patients with well differentiated (WD) liposarcoma, dedifferentiated (DD) liposarcoma or sarcoma other than liposarcoma |
| COHORT 11 - LUNG DRIVER | Other | Biological: Blood sampling C11 + FFPEPatients with Metastatic bronchial carcinoma activating alterations in EGFR (del 19; L858R) or KRAS G12C |
| COHORT 12 - LMD | Other | Biological: Blood sampling C12Patient with breast cancer and suspected with leptomeningeal metastases |
| COHORT 13 - RILA STAB | Other | Biological: Blood sampling C4/7/10/13Patients with breast cancer requiring radiotherapy, whatever the tumor stage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAlso: Tumor samplingblood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time | Biological | COHORT 1 BREAST TUMOR/PALBOCICLIB, COHORT 2 BREAST TUMOR / RIBOCICLIB |
| Blood sampling C3Blood samples will be collected at four key time points: * baseline (T1), * first scan assessment (T2), * second scan assessment (T3), * and progression (T4). | Biological | COHORT 3 - LUNG CANCER |
| Blood sampling C4/7/10/13Blood samples will be collected before any treatment | Biological | COHORT 10 - LPS, COHORT 13 - RILA STAB, COHORT 4 - CCRm, COHORT 7 - CIRCUS 2 |
| Blood sampling C5Blood 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 | COHORT 5 - T-DXd |
| Blood sampling C6Blood 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 | COHORT 6 - Glioma |
| Blood sampling C8Blood samples will be collected at five key time points: * At the inclusion * At follow-up visit 2 to 6, every 3 months | Biological | COHORT 8 - CTC-AXL Breast |
| Blood sampling C9Blood 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 | COHORT 9 - ImmunoTNBC |
| Blood sampling C11 + FFPEBlood 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 | COHORT 11 - LUNG DRIVER |
| Blood sampling C12Blood 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. | Biological | COHORT 12 - LMD |
Primary outcome
Estimation of the feasibility of the various blood tumoral biomarkers analysis
Time frame: 4 YEARS
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients"
13 secondary outcomes
COHORT 1 and 2 : rate of patients with a grade 3-4 of neutropenia Ciclib-related
Time frame: 4 YEARS
COHORT 1 and 2 : rate of patients with a hepatic toxicity Ciclib-related
Time frame: 4 YEARS
COHORT 3 : Correlation between response to immunotherapy (progressive versus non-progressive) and the number of circulating tumour cells (CTC) expressing the PDL1 marker at T1 (baseline)
Time frame: 4 years
COHORT 4 : To compare the expression of the circulating MS9 mRNA biomarker between healthy subjects and treatment-naive patients with metastatic colorectal cancer
Time frame: 1 year
COHORT 5 : to study the impact of baseline HER2+ CTCs detection on PFS under T-DXd treatment
Time frame: 4 years
COHORT 6 : To develop a computerised procedure for diagnosing glioma based on a nucleoside profile obtained by mass spectroscopy, using Artificial Intelligence
Time frame: 4 years
COHORT 7 : to optimise the culture of circulating tumour cells (CTCs)
Time frame: 4 years
COHORT 8 : to evaluate the concordance of CTC-AXL measurement (at inclusion) using the innovative EPIDROP technique and the CellSearch technique
Time frame: 4 years
COHORT 9 : to evaluate the predictive value of circulating immune populations for response to neo-adjuvant chemo-immunotherapy (according to pCR) in patients with early TNBCs, by performing an immunomonitoring before, during and after the treatment.
Time frame: 4 years
COHORT 10 : to identify a new non-invasive biological test for the diagnosis of LPS by measuring MDM2 DNA in circulating vesicles
Time frame: 4 years
COHORT 11 : to demonstrate a correlation between tumour progression under targeted therapy against EGFR (DEL19; L858R), KRAS G12C and the number of CTCs expressing the HES 1 marker at progression (T4)
Time frame: 4 years
COHORT 12 : to assess the sensitivity of the hepcidin assay in blood for the diagnosis of leptomeningeal metastases of breast cancer, the gold standard being cytological examination of CSF (up to 3 samples).
Time frame: 4 years
COHORT 13 : to validate the stability of the RILA at 24hrs (D1), 48hrs (D2), 72hrs (D3) and 96hrs (D4)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Results publication: PubMed 38132919Bardol T, Eslami-S Z, Masmoudi D, Alexandre M, Duboys de Labarre M, Bobrie A, D'Hondt V, Guiu S, Kurma K, Cayrefourcq L, Jacot W, Alix-Panabieres C. First evidence of AXL expression on circulating tumor cells in metastatic breast cancer patients: A proof-of-concept study. Cancer Med. 2024 Jan;13(1):e6843. doi: 10.1002/cam4.6843. Epub 2023 Dec 22.
- Results publication: PubMed 35456675Leenhardt F, Fiteni F, Gauthier L, Alexandre M, Guiu S, Firmin N, Pouderoux S, Viala M, Lossaint G, Gautier C, Mollevi C, Gracia M, Gongora C, Mbatchi L, Evrard A, Jacot W. Pharmacokinetic Variability Drives Palbociclib-Induced Neutropenia in Metastatic Breast Cancer Patients: Drug-Drug Interactions Are the Usual Suspects. Pharmaceutics. 2022 Apr 11;14(4):841. doi: 10.3390/pharmaceutics14040841.
- Results publication: PubMed 34286354Leenhardt F, Alexandre M, Guiu S, Pouderoux S, Beaujouin M, Lossaint G, Philibert L, Evrard A, Jacot W. Impact of pharmacist consultation at clinical trial inclusion: an effective way to reduce drug-drug interactions with oral targeted therapy. Cancer Chemother Pharmacol. 2021 Oct;88(4):723-729. doi: 10.1007/s00280-021-04331-0. Epub 2021 Jul 20.
- Results publication: PubMed 32623316Leenhardt F, Gracia M, Perrin C, Muracciole-Bich C, Marion B, Roques C, Alexandre M, Firmin N, Pouderoux S, Mbatchi L, Gongora C, Jacot W, Evrard A. Liquid chromatography-tandem mass spectrometric assay for the quantification of CDK4/6 inhibitors in human plasma in a clinical context of drug-drug interaction. J Pharm Biomed Anal. 2020 Sep 5;188:113438. doi: 10.1016/j.jpba.2020.113438. Epub 2020 Jun 22.
- Derived from this study: PubMed 42521839Leenhardt F, Jacot W, Lellouche L, Guiu S, Viala M, Firmin N, Payen A, Mbatchi LC, Fiteni F, Evrard A. Antacid co-treatment and pregnane X receptor genetic polymorphisms are survival determinants in patients treated with palbociclib. Breast Cancer Res Treat. 2026 Jul 28;218(2):20. doi: 10.1007/s10549-026-08041-0.
- Derived from this study: PubMed 42001180Kurma K, Bardol T, Mollevi C, Eslami-S Z, Garima F, Alexandre M, Bobrie A, Lossaint G, Massemin B, D'Hondt V, Guiu S, Cayrefourcq L, Jacot W, Alix-Panabieres C. Liquid biopsy reveals the immune status and protein profiles linked to CTC burden and clinical outcomes in metastatic breast cancer. J Exp Clin Cancer Res. 2026 Apr 18;45(1):111. doi: 10.1186/s13046-026-03709-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Blood sampling C3 and Blood sampling C4/7/10/13 in people with Cancer and Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact texier emmannuelle (0467613102, emmanuelle.texier@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the feasibility of the various blood tumoral biomarkers analysis (time frame: 4 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025541, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.