CancerALCINA4NCT05088395
Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
A study testing Blood sample and Biopsy in people with Cancer, run by Institut Curie at 2 sites in France.
Trial summary
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood sample and Biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,050 participants
- Where
- 2 sitesFrance
- Study dates
- 19 May 2022to 1 Jun 2031
- 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 treated for cancer at one of the participating center
- 18 years old or higher
- Signed informed consent form
- Patient not deprived of their liberty or under guardianship (including temporary guardianship)
- Patient covered by social security scheme
- Patient with no compliance issue (related to geographical, social or psychological reasons) for study follow up
Show all 11Show fewer
- Other additional criteria will be defined (defining tumor type and clinical setting), by cohort
- If a biopsy tumor sample is to be taken:
- Tumor considered as accessible by biopsy (at the investigator's discretion).
- Normal blood coagulation tests (if applicable, and in case of a non-superficial tumor lesion).
- No anticoagulant or antiaggregant treatment for the biopsy.
Who cannot join
- Pregnant and/or breast-feeding women depending on cohort.
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
Institut Curie
Paris, 75005
François-Clément Bidard, MD, 0147111607, francois-clement.bidard@curie.fr
François-Clément BIDARD, MD
- Recruiting
Institut Curie
Saint-Cloud, 92210
François-Clément BIDARD, MD, 0147111607, francois-clement.bidard@curie.fr
François-Clément BIDARD, MD
About this study
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort.
Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months. If a specific tumor sample is required, it will be collected only once during the study.
Read the detailed description
The ALCINA 4 study is a prospective biological cohort study based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy.
Circulating tumour biomarkers in blood have been the subject of much research for several decades, leading to the development in the 1980s of serum protein markers still in use today (CA15.3, ACE, CA125...). In the last decade, research has focused on circulating tumour cells (CTCs), circulating endothelial cells (CECs) and more recently on the detection of circulating tumour DNA (ctDNA) and exosomes (or microvesicles). While ctDNA seems to have a very promising future, other circulating elements such as microRNA are also part of what can/will be studied from a simple blood sample. Broadly speaking, the potential clinical interests of these circulating biomarkers are :
- diagnostic (diagnosis of cancer, or especially diagnosis of genetic mutations present in a known cancer)
- prognostic (to adapt the intensity of treatment to the expected outcome of the patient)
- predictive of the efficacy of targeted therapies (according to the mutational profile of the cancer)
- to study mechanisms of resistance during treatment . The multiplicity of these potential blood biomarkers is matched by a large number of detection techniques, for example for CTCs or ctDNA.
The major new challenge in research on circulating biomarkers is to replace molecular analyses on tumour tissue obtained by biopsy (e.g. the search for somatic cancer mutations) by a simple blood sample ("liquid biopsy"). This objective, which is technologically possible in the very short term and particularly interesting - both medically (for patients) and economically - requires the comparison of data from blood markers with those from tumour tissue samples. Furthermore, there is an important trend to combine several levels of analysis together (e.g. ctDNA and serum protein markers) to refine the performance of blood tests.
- Conditions
- Cancer
- Being tested
- Blood sample, Biopsy
- Keywords
- circulating biomarkers, Cohort
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months according to the cohorts.
BiopsyOther
If a specific tumor sample is required, it will be collected only once during the study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: "SENOLOC" | Other | Detecting residual disease after surgery is absolutely crucial in oncology, as this detection could allow the personalisation of post-operative treatments based on the presence of residual disease.
The laboratory wishes to develop a new technique for the detection of circulating tumour DNA, based on the recognition of translocation fragments in circulating DNA by shallow whole genome sequencing. This is an original approach, which to our knowledge has not been tested so far with the envisaged bioinformatics approach and could potentially be more sensitive than the techniques currently used to detect residual disease after surgical removal of localised (non-metastatic) breast cancer.
The analysis will therefore focus on the search for tumour chromosomal translocations, which will need to be differentiated from possible germline chromosomal translocations. The collection of constitutional DNA is therefore planned in this cohort. Receives: Other: Blood sample |
| Cohort 2: "Immuno-TNBC " | Other | The aim for this cohort is to study the role that variations in circulating tumour DNA might have as a marker associated with response during chemoimmunotherapy.
A fresh biopsy (subsequently stored frozen) is required for mutational profiling analysis (which will be used to track circulating tumour DNA in the blood). In addition, it will be used to analyse currently recognised biological tissue factors of response to chemoimmunotherapy (PD-L1 labelling, mutational load, ...) and to identify possible associations with circulating tumour DNA variations.
Constitutional DNA analysis is necessary for the determination of point mutations present in the tumour (to be differentiated from polymorphisms present at the constitutional level), as the determination of these mutations is essential to monitor circulating tumour DNA and will therefore be collected. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 3: "Trans-TNBC" | Other | The objective of this cohort is the development of new plasma tests, for example based on the detection of chromosomal translocations of circulating tumor DNA.
The hypothesis is that these tests would allow the detection of relapse, the prediction of treatment efficacy and the monitoring of treatment efficacy at different stages of cancer in patients with triple-negative breast cancer, either in the non-metastatic phase with planned neo-adjuvant treatment, or in the metastatic phase. The number of inclusions between these 2 populations (neo-adjuvant and metastatic) will be monitored at the operational level to avoid an excessive imbalance towards one group. Receives: Other: Blood sample |
| Cohort 4: "Treg" | Other | The purpose of this cohort, based on the previous results, is to:
1. quantify the expression level of target genes on tumor Regulatory T (Tregs) at the protein level,
2. perform multiparametric FACS analysis on blood and tumor samples from patients treated at the Institut Curie, with breast or ovary cancer and to understand the potential of these targets as biomarkers of disease.
In the context of this ALCINA-4 cohort n°4, for breast and ovary patients, 40 ml of blood will be collected and tumor fragments obtained from surgery (50 breast patients) or therapeutically required biopsy (30 ovary patients). No additional biopsy than the ones belonging to the therapeutic process will be performed in this protocol. Biopsies performed as part of standard of care will be used if sufficient material is available. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 5: "Pembro Neo" | Other | The purpose of this cohort is to determine the detection rate of circulating tumour DNA (ctDNA) before and after surgery in the blood of patients who received neoadjuvant treatment with chemoimmunotherapy for early triple-negative breast cancer (TNBC).
There will be two subgroups : patients who have not yet started neoadjuvant treatment (subcohort 1) and patients who have already started neoadjuvant treatment (subcohort 2).
Biopsy of a tumour lesion will be performed before the start of neoadjuvant treatment (only for subcohort 1). The collection of constitutional DNA, plasma and circulating tumour DNA are planned in this cohort at different time points. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 6: "THL" | Other | The main objective of this exploratory cohort is to characterize the detection rate of ctDNA before and during therapy with T-DXd (Trastuzumab deruxtecan) for patients with HER2-low metastatic breast cancer, requiring treatment with T-DXd.
Tumor biopsy will be performed after inclusion and before the start of treatment on cycle 1 day 1 for at least 30 patients. The collection of constitutional DNA, is planned in this cohort at different time points : T1 and T2 (before treatment start) are critical to evaluate the intra-patient reproducibility of liquid biomarkers. T3 will investigate the response to therapy while T4 will focus on resistance mechanisms. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 7:"CDK4/6 adjuvant" | Other | The purpose of this cohort is to determine the prognostic impact of circulating tumor DNA detection and monitoring in patients receiving a CDK4/6 inhibitor in adjuvant breast cancer.
50 ml of blood will be collected in EDTA tubes for constitutional DNA and plasma for research of circulating biomarkers at different time points (4 time points). Receives: Other: Blood sample |
| Cohort 8:"ctDNA adjuvant " | Other | The purpose of this cohort is to estimate the incidence of ctDNA detection in patients with early-stage breast cancer during follow-up to detect metastatic relapse earlier in asymptomatic patients.
ctDNA analysis will be performed using various techniques, including next-generation sequencing (NGS), with or without analysis of tumor tissue, taken as part of the standard care.
40 ml of blood samples will be collected at four time points:
* enrollment,
* 6 months (+/- 15 days),
* 12 months (+/- 15 days),
* 18 months (+/- 15 days) after inclusion. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 9:"ADN-CIRC-Poumon " | Other | The purpose of this cohort is to:
* Generate data on the levels and nature of circulating tumor DNA under chemo-immunotherapy.
* Monitor the evolution of the circulating immune response under systemic chemo-immunotherapy.
Tumor biopsy will be performed after inclusion and before the start of treatment.
50 ml of blood samples will be collected at four time points:
* At inclusion, before starting neoadjuvant treatment
* At the start of cycle 3 (C3J1) of neoadjuvant treatment
* At the time of surgery (after neoadjuvant treatment)
* At the start of monitoring, i.e. 3 months (+/- 1 month) after surgery. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 10: "UM TENEO" | Other | The purpose of this cohort is to :
* Evaluate recurrence-free survival (RFS) after R0/R1 surgery
* Assess effectiveness of Tebentafusp associated with surgery for patients with uveal melanoma metastases.
3 sub-cohorts :
* Sub-cohort 1: HLA-A*02:01-positive patients, eligible for R0 surgery and Tebentafusp (n=20)
* Sub-cohort 2: HLA-A*02:01-negative patients, eligible for R0 surgery and immunotherapy at next relapse (n=20)
* Sub-cohort 3: HLA-A*02:01 positive patients, not eligible for R0 surgery but eligible for Tebentafusp (n=20).
Tumor biopsy will be performed during surgery (sub-cohorts n°1 and 2) or after inclusion (sub-cohort n°3).
40 ml of blood will be collected in EDTA tubes for constitutional DNA and circulating DNA in plasma for research of biomarkers at 4 time points. Receives: Other: Blood sample; Other: Biopsy |
| Cohort 11: L1 CDK4/6 | Other | The purpose of this cohort is to :
* Characterize the kinetics of ctDNA during treatment with a CDK4/6 inhibitor.
* Study the links between ctDNA and common serum markers.
* Study the links between ctDNA and markers derived from metabolic imaging.
40 to 50 ml of blood will be collected in STRECK tubes for constitutional DNA and circulating DNA in plasma for research of biomarkers at different time points. Receives: Other: Blood sample |
| Cohort 12: PDX | Other | The purpose of this cohort is to correlate the circulating biomarkers with molecular analysis of patients-derived xenografts (PDX) established from breast cancers.
10 ml of blood will be collected in EDTA tubes for constitutional DNA at inclusion.
Tumor tissue samples (for PDX) will be taken at inclusion for PDX establishment. Receives: Other: Blood sample; Other: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of circulating biomarkers in cohort 1
Positivity rate of the detection technique (in %)
Measured: Baseline
Detection rate of circulating biomarkers in cohort 2
Positivity rate of the detection technique (in %)
Measured: Baseline
Detection rate of circulating biomarkers in cohort 2
Positivity rate of the detection technique (in %)
Measured: Before treatment
Detection rate of circulating biomarkers in cohort 2
Positivity rate of the detection technique (in %)
Measured: At 3 weeks of treatment
Detection rate of circulating biomarkers in cohort 2
Positivity rate of the detection technique (in %)
Measured: At 9 weeks of treatment
Detection rate of circulating biomarkers in cohort 2
Positivity rate of the detection technique (in %)
Measured: At disease progression
Detection rate of circulating biomarkers in cohort 1
Positivity rate of the detection technique (in %)
Measured: Before surgery
Detection rate of circulating biomarkers in cohort 1
Positivity rate of the detection technique (in %)
Measured: After surgery (from 3 to 5 weeks)
Detection rate of circulating biomarkers in cohort 1
Positivity rate of the detection technique (in %)
Measured: After surgery (from 2 to 3 months)
Detection rate of circulating biomarkers in cohort 3
Positivity rate of the detection technique (in %)
Measured: Baseline
Detection rate of circulating biomarkers in cohort 3
Positivity rate of the detection technique (in %)
Measured: At the end of cycle 1 (each cycle is 21 days)
Detection rate of circulating biomarkers in cohort 3
Positivity rate of the detection technique (in %)
Measured: After surgery (from 2 to 3 months)
Detection rate of circulating biomarkers in cohort 3
Positivity rate of the detection technique (in %)
Measured: At disease progression
Detection rate of circulating biomarkers in cohort 4
Positivity rate of the detection technique (in %)
Measured: At pre-surgery or before starting treatment
Detection rate of circulating biomarkers in cohort 4
Positivity rate of the detection technique (in %)
Measured: At 6 weeks after surgery or after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start19 May 2022
- Primary completion1 Jun 2031 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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). Detection study of blood tumor biomarkers and correlation with clinicopathological characteristics.
- Masking
- None (open label)
- Enrolment
- 2,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois-Clement BIDARD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088395
- Sponsor's protocol ID
- IC 2020-11
- Acronym
- ALCINA4
- Status last verified
- Apr 2026
- First submitted
- 28 Sep 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
- ClinicalTrials.gov ID
- NCT05088395
- Acronym / sponsor ID
- ALCINA4 / IC 2020-11
- Conditions
- Cancer
- Keywords
- circulating biomarkers, Cohort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,050 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 1 Jun 2031 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 21 Oct 2021 (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.
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort.
Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months. If a specific tumor sample is required, it will be collected only once during the study.
Detailed description
The ALCINA 4 study is a prospective biological cohort study based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy.
Circulating tumour biomarkers in blood have been the subject of much research for several decades, leading to the development in the 1980s of serum protein markers still in use today (CA15.3, ACE, CA125...). In the last decade, research has focused on circulating tumour cells (CTCs), circulating endothelial cells (CECs) and more recently on the detection of circulating tumour DNA (ctDNA) and exosomes (or microvesicles). While ctDNA seems to have a very promising future, other circulating elements such as microRNA are also part of what can/will be studied from a simple blood sample. Broadly speaking, the potential clinical interests of these circulating biomarkers are :
- diagnostic (diagnosis of cancer, or especially diagnosis of genetic mutations present in a known cancer)
- prognostic (to adapt the intensity of treatment to the expected outcome of the patient)
- predictive of the efficacy of targeted therapies (according to the mutational profile of the cancer)
- to study mechanisms of resistance during treatment . The multiplicity of these potential blood biomarkers is matched by a large number of detection techniques, for example for CTCs or ctDNA.
The major new challenge in research on circulating biomarkers is to replace molecular analyses on tumour tissue obtained by biopsy (e.g. the search for somatic cancer mutations) by a simple blood sample ("liquid biopsy"). This objective, which is technologically possible in the very short term and particularly interesting - both medically (for patients) and economically - requires the comparison of data from blood markers with those from tumour tissue samples. Furthermore, there is an important trend to combine several levels of analysis together (e.g. ctDNA and serum protein markers) to refine the performance of blood tests.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
- Model description
- 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). Detection study of blood tumor biomarkers and correlation with clinicopathological characteristics.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: "SENOLOC" | Other | Other: Blood sampleDetecting residual disease after surgery is absolutely crucial in oncology, as this detection could allow the personalisation of post-operative treatments based on the presence of residual disease. The laboratory wishes to develop a new technique for the detection of circulating tumour DNA, based on the recognition of translocation fragments in circulating DNA by shallow whole genome sequencing. This is an original approach, which to our knowledge has not been tested so far with the envisaged bioinformatics approach and could potentially be more sensitive than the techniques currently used to detect residual disease after surgical removal of localised (non-metastatic) breast cancer. The analysis will therefore focus on the search for tumour chromosomal translocations, which will need to be differentiated from possible germline chromosomal translocations. The collection of constitutional DNA is therefore planned in this cohort. |
| Cohort 2: "Immuno-TNBC " | Other | Other: Blood sample, Other: BiopsyThe aim for this cohort is to study the role that variations in circulating tumour DNA might have as a marker associated with response during chemoimmunotherapy. A fresh biopsy (subsequently stored frozen) is required for mutational profiling analysis (which will be used to track circulating tumour DNA in the blood). In addition, it will be used to analyse currently recognised biological tissue factors of response to chemoimmunotherapy (PD-L1 labelling, mutational load, ...) and to identify possible associations with circulating tumour DNA variations. Constitutional DNA analysis is necessary for the determination of point mutations present in the tumour (to be differentiated from polymorphisms present at the constitutional level), as the determination of these mutations is essential to monitor circulating tumour DNA and will therefore be collected. |
| Cohort 3: "Trans-TNBC" | Other | Other: Blood sampleThe objective of this cohort is the development of new plasma tests, for example based on the detection of chromosomal translocations of circulating tumor DNA. The hypothesis is that these tests would allow the detection of relapse, the prediction of treatment efficacy and the monitoring of treatment efficacy at different stages of cancer in patients with triple-negative breast cancer, either in the non-metastatic phase with planned neo-adjuvant treatment, or in the metastatic phase. The number of inclusions between these 2 populations (neo-adjuvant and metastatic) will be monitored at the operational level to avoid an excessive imbalance towards one group. |
| Cohort 4: "Treg" | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort, based on the previous results, is to: 1. quantify the expression level of target genes on tumor Regulatory T (Tregs) at the protein level, 2. perform multiparametric FACS analysis on blood and tumor samples from patients treated at the Institut Curie, with breast or ovary cancer and to understand the potential of these targets as biomarkers of disease. In the context of this ALCINA-4 cohort n°4, for breast and ovary patients, 40 ml of blood will be collected and tumor fragments obtained from surgery (50 breast patients) or therapeutically required biopsy (30 ovary patients). No additional biopsy than the ones belonging to the therapeutic process will be performed in this protocol. Biopsies performed as part of standard of care will be used if sufficient material is available. |
| Cohort 5: "Pembro Neo" | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort is to determine the detection rate of circulating tumour DNA (ctDNA) before and after surgery in the blood of patients who received neoadjuvant treatment with chemoimmunotherapy for early triple-negative breast cancer (TNBC). There will be two subgroups : patients who have not yet started neoadjuvant treatment (subcohort 1) and patients who have already started neoadjuvant treatment (subcohort 2). Biopsy of a tumour lesion will be performed before the start of neoadjuvant treatment (only for subcohort 1). The collection of constitutional DNA, plasma and circulating tumour DNA are planned in this cohort at different time points. |
| Cohort 6: "THL" | Other | Other: Blood sample, Other: BiopsyThe main objective of this exploratory cohort is to characterize the detection rate of ctDNA before and during therapy with T-DXd (Trastuzumab deruxtecan) for patients with HER2-low metastatic breast cancer, requiring treatment with T-DXd. Tumor biopsy will be performed after inclusion and before the start of treatment on cycle 1 day 1 for at least 30 patients. The collection of constitutional DNA, is planned in this cohort at different time points : T1 and T2 (before treatment start) are critical to evaluate the intra-patient reproducibility of liquid biomarkers. T3 will investigate the response to therapy while T4 will focus on resistance mechanisms. |
| Cohort 7:"CDK4/6 adjuvant" | Other | Other: Blood sampleThe purpose of this cohort is to determine the prognostic impact of circulating tumor DNA detection and monitoring in patients receiving a CDK4/6 inhibitor in adjuvant breast cancer. 50 ml of blood will be collected in EDTA tubes for constitutional DNA and plasma for research of circulating biomarkers at different time points (4 time points). |
| Cohort 8:"ctDNA adjuvant " | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort is to estimate the incidence of ctDNA detection in patients with early-stage breast cancer during follow-up to detect metastatic relapse earlier in asymptomatic patients. ctDNA analysis will be performed using various techniques, including next-generation sequencing (NGS), with or without analysis of tumor tissue, taken as part of the standard care. 40 ml of blood samples will be collected at four time points: * enrollment, * 6 months (+/- 15 days), * 12 months (+/- 15 days), * 18 months (+/- 15 days) after inclusion. |
| Cohort 9:"ADN-CIRC-Poumon " | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort is to: * Generate data on the levels and nature of circulating tumor DNA under chemo-immunotherapy. * Monitor the evolution of the circulating immune response under systemic chemo-immunotherapy. Tumor biopsy will be performed after inclusion and before the start of treatment. 50 ml of blood samples will be collected at four time points: * At inclusion, before starting neoadjuvant treatment * At the start of cycle 3 (C3J1) of neoadjuvant treatment * At the time of surgery (after neoadjuvant treatment) * At the start of monitoring, i.e. 3 months (+/- 1 month) after surgery. |
| Cohort 10: "UM TENEO" | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort is to : * Evaluate recurrence-free survival (RFS) after R0/R1 surgery * Assess effectiveness of Tebentafusp associated with surgery for patients with uveal melanoma metastases. 3 sub-cohorts : * Sub-cohort 1: HLA-A*02:01-positive patients, eligible for R0 surgery and Tebentafusp (n=20) * Sub-cohort 2: HLA-A*02:01-negative patients, eligible for R0 surgery and immunotherapy at next relapse (n=20) * Sub-cohort 3: HLA-A*02:01 positive patients, not eligible for R0 surgery but eligible for Tebentafusp (n=20). Tumor biopsy will be performed during surgery (sub-cohorts n°1 and 2) or after inclusion (sub-cohort n°3). 40 ml of blood will be collected in EDTA tubes for constitutional DNA and circulating DNA in plasma for research of biomarkers at 4 time points. |
| Cohort 11: L1 CDK4/6 | Other | Other: Blood sampleThe purpose of this cohort is to : * Characterize the kinetics of ctDNA during treatment with a CDK4/6 inhibitor. * Study the links between ctDNA and common serum markers. * Study the links between ctDNA and markers derived from metabolic imaging. 40 to 50 ml of blood will be collected in STRECK tubes for constitutional DNA and circulating DNA in plasma for research of biomarkers at different time points. |
| Cohort 12: PDX | Other | Other: Blood sample, Other: BiopsyThe purpose of this cohort is to correlate the circulating biomarkers with molecular analysis of patients-derived xenografts (PDX) established from breast cancers. 10 ml of blood will be collected in EDTA tubes for constitutional DNA at inclusion. Tumor tissue samples (for PDX) will be taken at inclusion for PDX establishment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient treated for cancer at one of the participating center
- 18 years old or higher
- Signed informed consent form
- Patient not deprived of their liberty or under guardianship (including temporary guardianship)
- Patient covered by social security scheme
Key exclusion criteria (1 listed)
- Pregnant and/or breast-feeding women depending on cohort.
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 sampleDepending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months according to the cohorts. | Other | Cohort 10: "UM TENEO", Cohort 11: L1 CDK4/6, Cohort 12: PDX, Cohort 1: "SENOLOC", Cohort 2: "Immuno-TNBC ", Cohort 3: "Trans-TNBC", Cohort 4: "Treg", Cohort 5: "Pembro Neo", Cohort 6: "THL", Cohort 7:"CDK4/6 adjuvant", Cohort 8:"ctDNA adjuvant ", Cohort 9:"ADN-CIRC-Poumon " |
| BiopsyIf a specific tumor sample is required, it will be collected only once during the study | Other | Cohort 10: "UM TENEO", Cohort 12: PDX, Cohort 2: "Immuno-TNBC ", Cohort 4: "Treg", Cohort 5: "Pembro Neo", Cohort 6: "THL", Cohort 8:"ctDNA adjuvant ", Cohort 9:"ADN-CIRC-Poumon " |
Primary outcome
Detection rate of circulating biomarkers in cohort 1
Time frame: Baseline
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2
Time frame: Baseline
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2
Time frame: Before treatment
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2
Time frame: At 3 weeks of treatment
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2
Time frame: At 9 weeks of treatment
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 2
Time frame: At disease progression
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 1
Time frame: Before surgery
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 1
Time frame: After surgery (from 3 to 5 weeks)
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 1
Time frame: After surgery (from 2 to 3 months)
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 3
Time frame: Baseline
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 3
Time frame: At the end of cycle 1 (each cycle is 21 days)
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 3
Time frame: After surgery (from 2 to 3 months)
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 3
Time frame: At disease progression
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 4
Time frame: At pre-surgery or before starting treatment
Positivity rate of the detection technique (in %)
Detection rate of circulating biomarkers in cohort 4
Time frame: At 6 weeks after surgery or after start of treatment
Positivity rate of the detection technique (in %)
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 14 Apr 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
Francois-Clement BIDARD principal investigator
Institut Curie
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 sample and Biopsy in people with Cancer, run by Institut Curie 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 11 inclusion and 1 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 14 Apr 2026. 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 Marie-Emmanuelle LEGRIER (0033156245649, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of circulating biomarkers in cohort 1 (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026.