Detecting double-positive (tumor marker/CD45+) cells in the blood of people with metastatic cancer
Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
This one-day study will test two blood-based methods to find double-positive tumor/CD45+ circulating cells in adults who are about to start treatment for various metastatic cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06967961 on ClinicalTrials.gov |
What this trial studies
This is a prospective, proof-of-concept pilot enrolling up to 450 adults with a range of metastatic cancers who have not yet begun anti-cancer therapy. With patient consent and before treatment starts, a single blood sample will be taken and analyzed by flow cytometry for all participants and by either Parsortix® or CellSearch® depending on the cancer type. The goal is to detect circulating cells that co-express tumor markers and CD45 (double-positive cells) using these complementary platforms. Each participant’s involvement consists of that single sampling visit, and results will be used to compare detection rates across methods and cancer types.
Who should consider this trial
Good fit: Adults (≥18) with one of the listed metastatic cancers who have not yet started systemic treatment, are affiliated with the French social security system, and can give informed consent are eligible.
Not a fit: Patients with localized (non-metastatic) disease, those already receiving anti-cancer therapy, pregnant or breastfeeding people, or those unable to comply with study procedures are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could enable a simple blood test to detect and track tumor-derived double-positive circulating cells across multiple metastatic cancers, potentially helping guide future monitoring or treatment decisions.
How similar studies have performed: Platforms like CellSearch® and Parsortix® are established for capturing circulating tumor cells, but using double-positive (tumor marker/CD45+) circulating cells as a biomarker remains largely exploratory with limited prior proof-of-concept data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors * 2\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet * 3\. Age ≥ 18 years * 4\. Patient affiliated to a French Social Security scheme * 5\. Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study. Exclusion Criteria: * 1\. Patient with localized disease. * 2\. Pregnant or breast-feeding women. * 3\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol. * 4\. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Where this trial is running
Toulouse
- Oncopole Claudius Regaud, IUCT-O — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Thibaud VALENTIN, MD
- Email: valentin.thibaud@iuct-oncopole.fr
- Phone: 0033 5 31 15 51 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.