Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer

Not Applicable

Not yet recruiting

• Conditions: Metastatic Breast Cancer; Metastatic Prostate Cancer

• Registration Number: NCT06904625
• Lead Sponsor: Institut Claudius Regaud

Brief Summary

This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.

Each patient will participate in the study for one day.

A total of 36 evaluable patients (18 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study Start: 2025-04
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+/HER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.
2. Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
3. Age ≥ 18 years and WHO ≤ 2
4. Patient affiliated to Social Security scheme in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.

Exclusion Criteria

1. Associated pathology(ies) likely to prevent the study procedure from running smoothly
2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
3. Patient deprived of liberty or under legal protection (guardianship, legal protection)
4. Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).	9 months after the study start	It is defined by the ratio of the number of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®) to the total number of patients.

Secondary Outcome Measures

Name	Time	Method
The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).	9 months after the study start	This is defined as the ratio of the number of patients with CTCs detected by the technique to the total number of patients.
The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).	9 months after the study start

Trial Locations

Locations (1)

IUCT-O; 🇫🇷 Toulouse, France