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NCT Number: NCT06904625

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
  • Age ≥ 18 years and WHO ≤ 2
  • Patient affiliated to Social Security scheme in France.
  • Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.

Exclusion criteria

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

Treatment and study plan

Taking blood samples before starting treatment

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Florence DALENC

CONTACT

[email protected]

05 31 15 51 22

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: CAPT CTC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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