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

Niguarda Hospital

Status: Enrolling

Conditions: Cardiac Masses

Treatments: Genetic: NGS-guided regimen: Regimen A

Study type: Observational

Funder types: Other

Identifiers

NCT07235865

4861

Details and patient eligibility

About

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

Full 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

Enrollment: 26 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

26 participants in 2 patient groups

benign cardiac lesions

Description:

patients diagnosed with benign cardiac lesions

Treatment:

Genetic: NGS-guided regimen: Regimen A

primary cardiac sarcomas

Description:

patients diagnosed with primary cardiac sarcomas (PCS)

Treatment:

Genetic: NGS-guided regimen: Regimen A