Non-invasive liquid biopsy to diagnose and monitor cardiac masses
Official title: Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study
Run by Niguarda Hospital · NCT07235865 · Data updated 2026-11-12
This project will test whether a blood-based liquid biopsy can detect tumor DNA and tell malignant from benign heart masses in people aged 12 and older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years and up |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Italia) |
| Status | Recruiting |
| Started | July 25, 2024 |
| Main results expected | January 1, 2025 |
| Study ends | December 25, 2026 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07235865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 12 and older with a suspected or confirmed cardiac mass who can give informed consent (or assent with guardian consent where applicable) and provide blood samples during routine care are ideal candidates.
✕Probably not a fit
Patients who cannot provide informed consent or whose lesions do not release detectable tumor DNA (for example some benign lesions or very small tumors) may not receive benefit from the liquid biopsy approach.
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 multicenter, prospective and retrospective observational study enrolling patients aged ≥12 with suspected or confirmed cardiac masses. Peripheral blood will be collected during routine venipuncture and analyzed by circulating tumor DNA (ctDNA) next-generation sequencing using commercial and/or academic assays, with samples shipped to a central laboratory. When available, matched tumor tissue from prior clinical biopsies or surgery will be analyzed and compared to the liquid biopsy results. Selected patients with malignant tumors may undergo serial blood draws for longitudinal tracking during cancer treatment.
Why it matters
Potential benefit: If successful, this approach could allow doctors to detect and monitor malignant heart tumors from a simple blood draw, potentially reducing the need for invasive tissue biopsies and speeding diagnosis.
How similar studies have gone: Liquid biopsy and ctDNA NGS have shown promise in detecting and monitoring other solid tumors, but applying these methods specifically to primary cardiac tumors is largely novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Age ≥12 years old 2. Suspected or confirmed diagnosis of a cardiac mass of any nature as assessed by standard clinical, radiological and/or pathological procedures. Exclusion Criteria 1\. Inability of the pa ent to fully understand and sign the informed consent.
Where it's running
-
Niguarda Hospital
Milan, Italia, Italy Recruiting
Study contacts
- Principal investigator: Katia Bencardino, MD — Niguarda Hospital
- Study coordinator: Katia Bencardino, MD
- Email: katia.bencardino@ospedaleniguarda.it
- Phone: +39026444
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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.