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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2025-12-25

Brief Summary

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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

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Detailed Description

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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

Conditions

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Cardiac Masses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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benign cardiac lesions

patients diagnosed with benign cardiac lesions

NGS-guided regimen: Regimen A

Intervention Type GENETIC

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

primary cardiac sarcomas

patients diagnosed with primary cardiac sarcomas (PCS)

NGS-guided regimen: Regimen A

Intervention Type GENETIC

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

Interventions

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NGS-guided regimen: Regimen A

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

Intervention Type GENETIC

Other Intervention Names

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collection of blood for NGS and archival tissue sample, where available

Eligibility Criteria

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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.