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

NCT06904625 | Recruiting

• 1 other identifier: 24GENE20
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer; Metastatic Prostate Cancer

Keywords

Circulating Tumor Cell; Metastatic Prostate Cancer; Metastatic Breast Cancer; CellSearch®; Parsortix®; SmartCatch®

Outcome Measures

Primary Outcomes (1)

• The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).

  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.

  9 months after the study start

Secondary Outcomes (2)

• The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).

  9 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®).

  9 months after the study start

Study Arms (1)

Patients with metastatic breast cancer or prostate cancer

OTHER

Other: Taking blood samples before starting treatment

Interventions

Taking blood samples before starting treatment OTHER

For each patient included, a blood sample will be taken (37 mL in total) for the CTCs detection using the 3 techniques (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).

Patients with metastatic breast cancer or prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years and WHO ≤ 2
• Patient affiliated to Social Security scheme in France.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

IUCT-O

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Florence DALENC

CONTACT

05 31 15 51 22; Dalenc.florence@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: August 14, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (1)