Breast Cancer, MetastaticPROBE-CTCNCT06807502
Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
A study testing The DM/DIV ScreenCell is the experimental product studied during this research in people with Breast Cancer, Metastatic and Breast Cancer Invasive, run by ScreenCell at 1 site in France.
Trial summary
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- The DM/DIV ScreenCell is the experimental product studied during this research
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2025to 30 Nov 2026
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants :
- Female with age greater than or equal to 18 years
- For participants with metastatic breast cancer:
- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.
- For participants with non-metastatic invasive breast cancer:
- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)
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- For healthy volunteers:
- Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion
- Participant with no history of cancer
Who cannot join
- For all participants:
- Male
- Age less than 18 years old
- Refusal to participate or withdrawal of consent
- Pregnant and/or breastfeeding women
- Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.
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- For healthy volunteers:
- History of cancer
- Detection of CTC (positive profile) during screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sina NASERIAN, Ph.D contact
France1 site, 1 recruiting
- Recruiting
CMC Ambroise Paré Hartmann
Neuilly-sur-Seine, 92200
Jean-Michel VANNETZEL, M.D.
Jean-François LLORY, M.D.
About this study
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.
The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up
- Conditions
- Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Being tested
- The DM/DIV ScreenCell is the experimental product studied during this research
- Keywords
- CTC, Circulating Tumor Cells, Detection, Breast Cancer, Follow-up, Liquid Biopsy, Blood Test
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The DM/DIV ScreenCell is the experimental product studied during this researchDevice
The product is not used directly on the subject, but on a blood sample taken from the participant.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Donor | Active comparator | Participants with no prior history of cancer and confirmed to be cancer-free at the time of inclusion, as evidenced by a negative mammogram performed within two years before enrollment Receives: Device: The DM/DIV ScreenCell is the experimental product studied during this research |
| Metastatic | Experimental | Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion, confirmed by a POSITIVE PET-Scan Receives: Device: The DM/DIV ScreenCell is the experimental product studied during this research |
| No metastatic | Experimental | Participants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory) Receives: Device: The DM/DIV ScreenCell is the experimental product studied during this research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the kinetics of CTC during treatment
Evolution of the number of CTC isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients. Average number of CTCs measured during the study (D0, W6, W12, W24, W36) with a tolerance of +/- 8 days for the visits
Measured: From enrollement to the end of follow up at 9 months
Secondary outcomes (1)
Molecular characterisation of CTC
Analysis of the expression of specific antigens and the presence of informative mutations on CTCs isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients during the study (D0, W6, W12, W24, W36)
Measured: From enrollement to the end of follow up at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start24 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, MetastaticStudies 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 with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device. A case-control study with longitudinal, prospective, single-center follow-up.
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ScreenCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AXELYS SANTE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807502
- Sponsor's protocol ID
- 2024-A01101-46
- Acronym
- PROBE-CTC
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
- ClinicalTrials.gov ID
- NCT06807502
- Acronym / sponsor ID
- PROBE-CTC / 2024-A01101-46
- Conditions
- Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Keywords
- CTC, Circulating Tumor Cells, Detection, Breast Cancer, Follow-up, Liquid Biopsy, Blood Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- ScreenCellIndustry (pharma, biotech, devices)
- Collaborators
- AXELYS SANTE
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Feb 2025 (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.
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.
The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional study with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device. A case-control study with longitudinal, prospective, single-center follow-up.
| Arm | Type | Receives |
|---|---|---|
| Healthy Donor | Active comparator | Device: The DM/DIV ScreenCell is the experimental product studied during this researchParticipants with no prior history of cancer and confirmed to be cancer-free at the time of inclusion, as evidenced by a negative mammogram performed within two years before enrollment |
| Metastatic | Experimental | Device: The DM/DIV ScreenCell is the experimental product studied during this researchParticipants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion, confirmed by a POSITIVE PET-Scan |
| No metastatic | Experimental | Device: The DM/DIV ScreenCell is the experimental product studied during this researchParticipants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female with age greater than or equal to 18 years
- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.
- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)
- Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion
- Participant with no history of cancer
Key exclusion criteria (9 listed)
- Male
- Age less than 18 years old
- Refusal to participate or withdrawal of consent
- Pregnant and/or breastfeeding women
- Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.
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 |
|---|---|---|
| The DM/DIV ScreenCell is the experimental product studied during this researchThe product is not used directly on the subject, but on a blood sample taken from the participant. | Device | Healthy Donor, Metastatic, No metastatic |
Primary outcome
Evolution of the kinetics of CTC during treatment
Time frame: From enrollement to the end of follow up at 9 months
Evolution of the number of CTC isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients. Average number of CTCs measured during the study (D0, W6, W12, W24, W36) with a tolerance of +/- 8 days for the visits
1 secondary outcome
Molecular characterisation of CTC
Time frame: From enrollement to the end of follow up at 9 months
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 24 Apr 2026.
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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.
Sina NASERIAN, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The DM/DIV ScreenCell is the experimental product studied during this research in people with Breast Cancer, Metastatic and Breast Cancer Invasive, run by ScreenCell at 1 site 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 9 inclusion and 9 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 24 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 1 site 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 Jessica GROULT, Ph.D (0033669645318, jgroult@screencell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the kinetics of CTC during treatment (time frame: From enrollement to the end of follow up at 9 months). 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 24 Apr 2026.