Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Recruiting · NCT06807502 · Interventional (participants receive a specific treatment) · Lead sponsor: ScreenCell
View the official record on ClinicalTrials.gov →Interventions studied
The DM/DIV ScreenCell is the experimental product studied during this research
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- CMC Ambroise Paré Hartmann - Neuilly-sur-Seine, France