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

April 21, 2026 updated by: ScreenCell

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Neuilly-sur-Seine, France, 92200
        • Recruiting
        • CMC Ambroise Paré Hartmann
        • Principal Investigator:
          • Jean-Michel VANNETZEL, M.D.
        • Sub-Investigator:
          • Jean-François LLORY, M.D.
        • Sub-Investigator:
          • Marie-Laure CHABI, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA

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)

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The product is not used directly on the subject, but on a blood sample taken from the participant.
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
The product is not used directly on the subject, but on a blood sample taken from the participant.
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
The product is not used directly on the subject, but on a blood sample taken from the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollement to the end of follow up at 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular characterisation of CTC
Time Frame: From enrollement to the end of follow up at 9 months
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)
From enrollement to the end of follow up at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ScreenCell

Collaborators

AXELYS SANTE

Investigators

  • Study Director: Sina NASERIAN, ScreenCell

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01101-46

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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