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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorScreenCell

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female with age greater than or equal to 18 years

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

Disqualifiers

Male

Age less than 18 years old

Refusal to participate or withdrawal of consent

Pregnant and/or breastfeeding women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

93 Participants
are divided into 3 treatment groups
Group A: Healthy DonorActive comparator 1 intervention
Group B: MetastaticExperimental treatment 1 intervention
Group C: No metastaticExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evolution of the kinetics of CTC during treatment

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

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

Secondary outcomes

1

Molecular characterisation of CTC

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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ScreenCell

Lead sponsor

AXELYS SANTE

Collaborator