NCT06904625

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Aug 2025Nov 2026

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

August 14, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

March 25, 2025

Last Update Submit

May 22, 2026

Conditions

Metastatic Breast CancerMetastatic Prostate Cancer

Keywords

Circulating Tumor CellMetastatic Prostate CancerMetastatic Breast CancerCellSearch®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.

    15 months after the study start

Secondary Outcomes (2)

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

    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®).

    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.

    15 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 treatmentOTHER

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.

Patients with metastatic breast cancer or prostate cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCT-O

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Florence DALENC

CONTACT

05 31 15 51 22Dalenc.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 (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations

FR(1)