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

May 22, 2026 updated by: Institut Claudius Regaud

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with metastatic breast cancer or prostate cancer
Other: Taking blood samples before starting treatment

For patient included in the metastatic breast cancer and prostate cancer, a blood sample will be taken (37 mL in total) for the CTCs detection using the 3 technologies (CellSearch®, Parsortix® and SmartCatch®).

For 3 patients only, an additional blood volume (18 mL) will also be collected for tcDNA detection (exploratory analysis of 3 patients).

For patient included in the metastatic breast cancer complementary cohort, a blood sample will be taken (56 mL in total) for the CTCs detection using Parsortix® and SmartCatch® technologies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
Time Frame: 15 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.
15 months after the study start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).
Time Frame: 15 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.
15 months after the study start
The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).
Time Frame: 15 months after the study start
15 months after the study start

Other Outcome Measures

Outcome Measure
Time Frame
The rate of patients with CTCs (CK+/CD45-) detected using different tubes by Parsortix® and SmartCatch® technologies.
Time Frame: 15 months after the study start
15 months after the study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24GENE20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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