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NCT Number: NCT06807502

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, 92200, France

Location status: Recruiting

Location contact

Jean-François LLORY, M.D.

SUB_INVESTIGATOR

Jean-Michel VANNETZEL, M.D.

PRINCIPAL_INVESTIGATOR

Marie-Laure CHABI, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Evolution of the kinetics of CTC during treatment

    Time frame: 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

Secondary outcomes

  1. Molecular characterisation of CTC

    Time frame: From enrollement to the end of follow up at 9 months

    Analysis of the expression of specific antigens and the presence of informative mutations on CTCs isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients during the study (D0, W6, W12, W24, W36)

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica GROULT, Ph.D

CONTACT

[email protected]

0033669645318

Sina NASERIAN, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

ScreenCell

Industry

Collaborators

  • AXELYS SANTE

Registry information

Acronym: PROBE-CTC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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