An observational study in Cardiac Masses, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Niguarda Hospital · Observational
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
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
Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass
Exclusion Criteria
1. Inability of the pa ent to fully understand and sign the informed consent.
patients diagnosed with benign cardiac lesions
Genetic: NGS-guided regimen: Regimen A
patients diagnosed with primary cardiac sarcomas (PCS)
Genetic: NGS-guided regimen: Regimen A
Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture
Also known as: collection of blood for NGS and archival tissue sample, where available
Molecular profile
Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile
Time frame: Jul2024-Jul2029
Molecular targets
Collection and alalysis of blood and tissue samples from both cases and control in term of molecular profile. To identify the percentage and types of actionable molecular targets that could be amenable of potential targeted treatment according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). To test the concordance of liquid biopsy NGS ctDNA with tissue-based NGS analyses in a subset of patients where both tissue and blood samples are available.
Time frame: Jul2024-Jul2029
Plan to share: Undecided — Not decided yet
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Niguarda Hospital