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Recruiting NCT06807502

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

No phase Interventional Breast Cancer, Metastatic Breast Cancer Invasive Breast Cancer Early Stage Breast Cancer (Stage 1-3)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The DM/DIV ScreenCell is the experimental product studied during this research.
Who it may be relevant to
Registry conditions: Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • 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.

Primary outcome measures

  • Evolution of the kinetics of CTC during treatment [Time frame: From enrollement to the end of follow up at 9 months]
Secondary outcome measures (1)
  • Molecular characterisation of CTC [Time frame: From enrollement to the end of follow up at 9 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CMC Ambroise Paré Hartmann — Neuilly-sur-Seine

Identifiers

NCT: NCT06807502 · 2024-A01101-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗