RecruitingNCT07235865

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


Sponsor

Niguarda Hospital

Enrollment

26 participants

Start Date

Jul 25, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 12 Years

Inclusion Criteria2

  • 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.

Exclusion Criteria1

  • \. Inability of the pa ent to fully understand and sign the informed consent.

Interventions

GENETICNGS-guided regimen: Regimen A

Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture


Locations(1)

Niguarda Hospital

Milan, Italia, Italy

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NCT07235865