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Are CK+/CD45+ Double-Positive Circulating Cells of Tumor-origin? Characterization in METAstatic Breast Cancer

NCT06408038 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-18

No results posted yet for this study

Summary

A prospective, single-centre, proof-of-concept pilot study in patients with metastatic breast cancers (MBC) (whatever the immunohistochemical subtype) treated at the IUCT-O. Eligible patients will be selected and informed of this study during a medical consultation for cancer that has metastasised, has relapsed or is progressing metastatically, by medical oncologists at the Oncopole Claudius Regaud (OCR). Then, with the patient's agreement and before the start of anti-tumour treatment, a blood sample will be taken to detect DP-circulating cells. A breast cancer tumour sample (non-bone metastasis or, failing that, primary tumour) must be available (FFPE archived tumour block).

Each patient will participate in the study for one day.

60 patients will be included in this interventional study.

Conditions

Interventions

OTHER

For each patient included, the samples described below will be collected:

* A single blood sample will be taken before initiation of the metastatic treatment line. The volume of total blood sampled is 34mL. * A tumour sample (FFPE block already archived) from a metastasis (other than bone) if available or, failing this, from the primary breast tumour, will be sent to the sponsor in order to meet the objectives of the study. Once the blood sample has been taken, patients will have completed their participation in the study.

Sponsors & Collaborators

  • Fondation Toulouse Cancer Santé

    collaborator UNKNOWN

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-10-08
Completion
2025-10-08

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06408038 on ClinicalTrials.gov