Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
NCT ID: NCT06807502
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
93 participants
INTERVENTIONAL
2025-02-24
2026-11-30
Brief Summary
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The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
A case-control study with longitudinal, prospective, single-center follow-up.
OTHER
NONE
Study Groups
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No metastatic
Participants with invasive breast cancer but non-metastatic
The DM/DIV ScreenCell is the experimental product studied during this research
The product is not used directly on the subject, but on a blood sample taken from the participant.
Healthy Donor
Participants with no history of cancer and free from any cancer at the time of inclusion
The DM/DIV ScreenCell is the experimental product studied during this research
The product is not used directly on the subject, but on a blood sample taken from the participant.
Metastatic
Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion
The DM/DIV ScreenCell is the experimental product studied during this research
The product is not used directly on the subject, but on a blood sample taken from the participant.
Interventions
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The DM/DIV ScreenCell is the experimental product studied during this research
The product is not used directly on the subject, but on a blood sample taken from the participant.
Eligibility Criteria
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Inclusion Criteria
* 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 one year before inclusion
* Participant with no history of cancer
Exclusion Criteria
* 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 participants with breast cancer:
\- Absence of CTC during screening
For healthy volunteers:
* History of cancer
* Detection of CTC (positive profile) during screening
18 Years
FEMALE
Yes
Sponsors
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AXELYS SANTE
UNKNOWN
ScreenCell
INDUSTRY
Responsible Party
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Locations
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CMC Ambroise Paré Hartmann
Neuilly-sur-Seine, , France
Countries
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Central Contacts
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Other Identifiers
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2024-A01101-46
Identifier Type: -
Identifier Source: org_study_id
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