ClinicalTrials.gg
RecruitingNCT06807502PROBE-CTCUpdated Apr 24, 2026

Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device

An interventional study of The DM/DIV ScreenCell is the experimental product studied during this research in Breast Cancer, Metastatic, Breast Cancer Invasive and Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by ScreenCell. Recruiting at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by ScreenCell · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up

02

Conditions studied

  • 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
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 93 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with ScreenCell as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

For all participants :

  • Female with age greater than or equal to 18 years

For participants with 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)

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

Exclusion criteria

EXCLUSION CRITERIA

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.

For healthy volunteers:

  • History of cancer
  • Detection of CTC (positive profile) during screening
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (estimated)

Study arms

  • Active comparator
    Healthy Donor

    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

    Device: The DM/DIV ScreenCell is the experimental product studied during this research

  • Experimental
    Metastatic

    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

    Device: The DM/DIV ScreenCell is the experimental product studied during this research

  • Experimental
    No metastatic

    Participants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory)

    Device: The DM/DIV ScreenCell is the experimental product studied during this research

Interventions

  • DeviceThe DM/DIV ScreenCell is the experimental product studied during this research

    The product is not used directly on the subject, but on a blood sample taken from the participant.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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)

    Time frame: From enrollement to the end of follow up at 9 months

07

Study locations

1 of 1 sites recruiting
  • CMC Ambroise Paré Hartmann
    Neuilly-sur-Seine, 92200, France
    Recruiting
    • Jean-Michel VANNETZEL, M.D. · Principal investigator
    • Jean-François LLORY, M.D. · Sub investigator
    • Marie-Laure CHABI, M.D. · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Sep 2026, 19 months after the start.

Of 110 industry-sponsored interventional studies with no phase under Breast Neoplasms, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 74. This study's planned 19 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2025
First posted
Feb 4, 2025
StartActual
Feb 24, 2025
Primary completionEst.
Sep 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Apr 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06807502
Lead sponsor
ScreenCell
Collaborators
AXELYS SANTE
Responsible party
Sponsor
First posted
Feb 4, 2025
Start date
Feb 24, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 24, 2026

Study contacts

Jessica GROULT, Ph.D
Contact
jgroult@screencell.com
0033669645318
Sina NASERIAN, Ph.D
Contact
snaserian@screencell.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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