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

Обзор

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.

Вмешательства

• Другое Taking blood samples before starting treatment
  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

Первичные конечные точки

• The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®). [Срок оценки: 15 months after the study start]

Вторичные конечные точки (2)

• The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®). [Срок оценки: 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®). [Срок оценки: 15 months after the study start]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• IUCT-O — Toulouse

Идентификаторы

NCT: NCT06904625 · 24GENE20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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