Niguarda Hospital
Milan, Italia, 20262, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT07235865
Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- Inability of the pa ent to fully understand and sign the informed consent.
Treatment and study plan
NGS-guided regimen: Regimen A
GeneticLiquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture
Other names: collection of blood for NGS and archival tissue sample, where available
Primary outcomes
-
Molecular profile
Time frame: Jul2024-Jul2029
Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile
Secondary outcomes
-
Molecular targets
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Niguarda Hospital
Other
Registry information
Official study title
Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study
Acronym: CarMA
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Nov 19, 2025
- Registry last updated
- Apr 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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