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

ScreenCell

Status: Enrolling

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

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06807502

2024-A01101-46

Details and patient eligibility

About

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

Enrollment: 93 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Healthy Donor

Active Comparator group

Description:

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

Treatment:

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

Metastatic

Experimental group

Description:

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

Treatment:

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

No metastatic

Experimental group

Description:

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

Treatment:

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