Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Taking blood samples before starting treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer, Metastatic Prostate Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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
Primary outcome measures
- The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®). [Time frame: 15 months after the study start]
Secondary outcome measures (2)
- The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®). [Time frame: 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®). [Time frame: 15 months after the study start]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- IUCT-O — Toulouse
Identifiers
NCT: NCT06904625 · 24GENE20