Non-invasive liquid biopsy to diagnose and monitor cardiac masses
Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study
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 |
|---|---|
| Enrollment | 26 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Niguarda Hospital Academic / other |
| Locations | 1 site (Milan, Italia) |
| Trial ID | NCT07235865 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italia
- 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
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.