Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06807502

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

Led by ScreenCell · Updated on 2026-04-24

93

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

ScreenCell

Lead Sponsor

A

AXELYS SANTE

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of liquid biopsy with ScreenCell technology to detect and measure circulating tumor cells (CTCs) in women during breast cancer follow-up. The study focuses on how the number of CTCs changes over time and aims to provide information on the stage and molecular characteristics of breast cancer during patient monitoring. The study involves three groups: women with no cancer history confirmed by a recent negative mammogram, women with metastatic breast cancer or relapse confirmed by a positive PET scan, and women with invasive but non-metastatic breast cancer. The ScreenCell device is used on blood samples taken from participants to detect CTCs. The study is non-randomized and does not involve any masking or blinding. Participants will be followed for 9 months from enrollment to track changes in CTC levels and their molecular characteristics. Assessments include blood sample collection for CTC detection, with monitoring throughout treatment or follow-up. The primary outcome is the evolution of CTC kinetics during treatment, while secondary outcomes analyze molecular features of detected CTCs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Participants with metastatic breast cancer or metastatic relapse with change of therapy at inclusion
  • Participants with non-metastatic invasive breast cancer who have not received any treatment at inclusion
  • Healthy female volunteers with no cancer history and a normal mammogram within two years before inclusion
Not Eligible

You will not qualify if you...

  • Male
  • Age under 18 years
  • Refusal to participate or withdrawal of consent
  • Pregnant and/or breastfeeding women
  • Discovery of a cancer other than breast cancer during follow-up
  • Healthy volunteers with history of cancer
  • Healthy volunteers with positive circulating tumor cell detection during screening

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 9 months

Participants provide blood samples during their breast cancer follow-up to evaluate circulating tumor cells using the ScreenCell device.

Multiple visits for blood sample collection during follow-up

Trial Site Locations

Total: 1 location

1

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, France, 92200

Actively Recruiting

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Research Team

J

Jessica GROULT, Ph.D

S

Sina NASERIAN, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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