Clinical trial NCT06904625: Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
Official title: Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Metastatic Prostate Cancer
Keywords: Circulating Tumor Cell
Metastatic Prostate Cancer
Metastatic Breast Cancer
CellSearch®
Parsortix®
SmartCatch®
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
timeFrame: 9 months after the study start
Secondary outcomes:
measure: The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).
timeFrame: 9 months after the study start
measure: The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).
timeFrame: 9 months after the study start
Other outcomes:
Locations:
city: Toulouse
country: France
facility: IUCT-O
Study officials:
References: