About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Taking blood samples before starting treatment
Other interventionFor 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).
This is defined as the ratio of the number of patients with CTCs detected by the technique to the total number of patients.
The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).
Other outcomes
The rate of patients with CTCs (CK+/CD45-) detected using different tubes by Parsortix® and SmartCatch® technologies.
Sponsors and contacts
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