Detecting double-positive (tumor marker/CD45+) cells in the blood of people with metastatic cancer
Official title: Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
Run by Institut Claudius Regaud · NCT06967961 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | July 23, 2029 |
| Study ends | July 23, 2029 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT06967961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.