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

NCT ID: NCT06807502

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer, Metastatic Breast Cancer Invasive Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No metastatic

Participants with invasive breast cancer but non-metastatic

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Healthy Donor

Participants with no history of cancer and free from any cancer at the time of inclusion

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

For all participants :

* 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 one year before inclusion
* Participant with no history of cancer

Exclusion Criteria

For all participants:

* 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 participants with breast cancer:

\- Absence of CTC during screening

For healthy volunteers:

* History of cancer
* Detection of CTC (positive profile) during screening
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AXELYS SANTE

UNKNOWN

Sponsor Role collaborator

ScreenCell

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jessica GROULT, Ph.D

Role: CONTACT

0033669645318

Sina NASERIAN, Ph.D

Role: CONTACT

Other Identifiers

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2024-A01101-46

Identifier Type: -

Identifier Source: org_study_id

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