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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorNiguarda Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • NGS-guided regimen: Regimen A

    Genetic

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

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: benign cardiac lesions1 intervention
Group B: primary cardiac sarcomas1 intervention

Trial outcomes

Primary outcomes

1

Molecular profile

Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile

Time frame
Jul2024-Jul2029

Secondary outcomes

1

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.

Time frame
Jul2024-Jul2029

Other outcomes

Sponsors and contacts

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