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Clinical Trials in France / NCT06807502
Recruiting Not applicable

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

NCT06807502 · tracked via the Priya Life Science France tracker
Sponsor
ScreenCell
Phase
Not applicable
Started
2025-02-24
Last updated
2026-04-24

Condition(s) studied

Breast Cancer, MetastaticBreast Cancer InvasiveBreast Cancer Early Stage Breast Cancer (Stage 1-3)

Investigational drug(s) / intervention(s)

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

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.

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Evolution of the kinetics of CTC during treatment — 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

Trial sites (1)

FacilityCityRegionStatus
CMC Ambroise Paré Hartmann Neuilly-sur-Seine France Recruiting

Other trials for the same condition

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer Recruiting
A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06807502 on ClinicalTrials.gov ↗ ← All trials in France