Cardiac Masses
Conditions
Keywords
Early-Onset Colorectal Cancer
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
Detailed 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
Interventions
Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture
Sponsors
Niguarda Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular profile | Jul2024-Jul2029 | Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Molecular targets | Jul2024-Jul2029 | 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. |
Countries
Italy
Contacts
CONTACTKatia Bencardino, MD
CONTACTGiorgio Patelli, MD
PRINCIPAL_INVESTIGATORKatia Bencardino, MD
Niguarda Hospital
Outcome results
None listed