About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥12 years old
Suspected or confirmed diagnosis of a cardiac mass of any nature as assessed by standard clinical, radiological and/or pathological procedures.
Disqualifiers
None
Trial population
control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass
Trial design
Case-control
Other
Treatments tested in this trial
NGS-guided regimen: Regimen A
GeneticLiquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture
Treatment groups
Trial outcomes
Primary outcomes
Molecular profile
Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile
Secondary outcomes
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.
Sponsors and contacts
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