Recruiting NCT07235865

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

Trial Parameters

Condition Cardiac Masses

Sponsor Niguarda Hospital

Study Type OBSERVATIONAL

Phase N/A

Enrollment 26

Sex ALL

Min Age 12 Years

Max Age N/A

Start Date 2024-07-25

Completion 2025-01-01

Interventions

NGS-guided regimen: Regimen A

Brief 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

Eligibility 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.

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