NCT07235865

Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy

Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: Niguarda Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a nonprofit, observational, prospective and retrospective,multicenter study in a population of young and adult patients ≥12 years with a diagnosis of a cardiac mass. The study will include both patients with masses of unknown pathological diagnosis and patients with a known histology of benign or malignant tumors. We predict a case-control allocation ratio of 1:1 between cardiac malignant tumors and benign lesions. Peripheral blood will be collected at participating centers during routine venipuncture,processed and then shipped for liquid biopsy ctDNA NGS analyses. If available, in malignant cases, matched tumor tissue samples collected as per clinical practice solid biopsies or surgery will be used for analyses. Longitudinal tracking through serial blood draws could be performed in selected cases of patients with cardiac malignancies who receive cancer treatment

Detailed description

This is a nonprofit, observational, prospective and retrospective, multicenter study. The primary objectives of this study are: (i) to assess the efficacy of liquid biopsy using ctDNA NGS in identifying tumor-specific somatic alterations in patients with cardiac malignancies, particularly primary cardiac sarcomas (PCS), and to differentiate these from benign cardiac lesions. Liquid biopsy, consisting of a venous blood samplecollected during routine venipuncture, will assess the nature of circulating DNA by a commercial NGS assay (i.e., Guardant Infinity, Guardant Health) and/or academic assays. When solid biopsy is available since previouslyperformed as per clinical practice, tumor DNA will be assessed by a commercial issue NGS assay (i.e., FoundationOne, Foundation Medicine) and/or academic assays

Conditions

• Cardiac Masses

Interventions

Type	Name	Description
GENETIC	NGS-guided regimen: Regimen A	Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture

Timeline

• Start date: 2024-07-25
• Primary completion: 2025-01-01
• Completion: 2026-12-25
• First posted: 2025-11-19
• Last updated: 2026-04-15

Locations

1 site across 1 country: Italy