NCT06807502

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Nov 2026

First Submitted

Initial submission to the registry

January 14, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

January 14, 2025

Last Update Submit

April 21, 2026

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)Breast Cancer, MetastaticBreast Cancer Invasive

Keywords

CTCCirculating Tumor CellsDetectionBreast CancerFollow-upLiquid BiopsyBlood Test

Outcome Measures

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

    From enrollement to the end of follow up at 9 months

Secondary Outcomes (1)

  • Molecular characterisation of CTC

    From enrollement to the end of follow up at 9 months

Study Arms (3)

Healthy Donor

ACTIVE COMPARATOR

Participants with no prior history of cancer and confirmed to be cancer-free at the time of inclusion, as evidenced by a negative mammogram performed within two years before enrollment

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

Metastatic

EXPERIMENTAL

Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion, confirmed by a POSITIVE PET-Scan

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

No metastatic

EXPERIMENTAL

Participants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory)

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

Interventions

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

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

Healthy DonorMetastaticNo metastatic

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals who self-identify as female are eligible to participate to evaluate breast cancer within a homogenized cohort, ensuring more relevant and reliable biostatistical analyses
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all participants :
  • Female with age greater than or equal to 18 years
  • For participants with metastatic breast cancer:
  • For participants with non-metastatic invasive breast cancer:
  • For healthy volunteers:
  • Participant with no history of cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, 92200, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica GROULT, Ph.D

CONTACT

0033669645318jgroult@screencell.com

Sina NASERIAN, Ph.D

CONTACT

snaserian@screencell.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Interventional study with minimal risk and constraints (RIPH2) comparative and open, non-randomized, on an in vitro diagnostic medical device. A case-control study with longitudinal, prospective, single-center follow-up.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 4, 2025

Study Start

February 24, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 24, 2026

Record last verified: 2026-03

Locations

FR(1)