Cardiac MassesCarMANCT07235865
Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy
An observational study of Cardiac Masses, run by Niguarda Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cardiac Masses
- What is being tested?
- NGS-guided regimen: Regimen A
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2024to 25 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass
Who may be able to join
- 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.
Who cannot join
- 1. Inability of the pa ent to fully understand and sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Niguarda Hospital
Milan, Italia, 20262
Katia Bencardino, MD, +39026444 ext. 3695, katia.bencardino@ospedaleniguarda.it
Giorgio Patelli, MD, +39026444 ext. 3695, giorgio.patelli@ospedaleniguarda.it
About this study
Official title: Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study
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
Read the 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
- Conditions
- Cardiac Masses
- Being tested
- NGS-guided regimen: Regimen A
- Keywords
- Early-Onset Colorectal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS-guided regimen: Regimen AGenetic
Also called collection of blood for NGS and archival tissue sample, where available
Liquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture
| Study group | Role | What they receive |
|---|---|---|
| benign cardiac lesions | patients diagnosed with benign cardiac lesions Receives: Genetic: NGS-guided regimen: Regimen A | |
| primary cardiac sarcomas | patients diagnosed with primary cardiac sarcomas (PCS) Receives: Genetic: NGS-guided regimen: Regimen A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profile
Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile
Measured: 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.
Measured: Jul2024-Jul2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start25 Jul 2024
- Primary completion1 Jan 2025
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac MassesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katia Bencardino, MD, Principal investigator, Niguarda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235865
- Sponsor's protocol ID
- 4861
- Acronym
- CarMA
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Diagnosis and Monitoring of Cardiac Masses by Liquid Biopsy: The CarMA Study
- ClinicalTrials.gov ID
- NCT07235865
- Acronym / sponsor ID
- CarMA / 4861
- Conditions
- Cardiac Masses
- Keywords
- Early-Onset Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign cardiac lesions | – | Genetic: NGS-guided regimen: Regimen Apatients diagnosed with benign cardiac lesions |
| primary cardiac sarcomas | – | Genetic: NGS-guided regimen: Regimen Apatients diagnosed with primary cardiac sarcomas (PCS) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Inability of the pa ent to fully understand and sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGS-guided regimen: Regimen AAlso: collection of blood for NGS and archival tissue sample, where availableLiquid biopsy, consisting of a venous blood sample, will be collected during routine venipuncture | Genetic | benign cardiac lesions, primary cardiac sarcomas |
Primary outcome
Molecular profile
Time frame: Jul2024-Jul2029
Collect and analyse blood and tissue samples from both cases and control in terms of molecular profile
1 secondary outcome
Molecular targets
Time frame: Jul2024-Jul2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. Not decided yet
Related trials for Cardiac Masses
Enrolling by invitationObservational study
Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)
Cardiac Masses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katia Bencardino, MD principal investigator
Niguarda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Masses, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katia Bencardino, MD (+39026444 ext. 3695, katia.bencardino@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profile (time frame: Jul2024-Jul2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.