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

NCT07235865 | Recruiting

• 1 other identifier: 4861
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Masses

Keywords

Early-Onset Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Molecular profile

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

  Jul2024-Jul2029

Secondary Outcomes (1)

• Molecular targets

  Jul2024-Jul2029

Study Arms (2)

benign cardiac lesions

patients diagnosed with benign cardiac lesions

Genetic: NGS-guided regimen: Regimen A

primary cardiac sarcomas

patients diagnosed with primary cardiac sarcomas (PCS)

Genetic: NGS-guided regimen: Regimen A

Interventions

NGS-guided regimen: Regimen A GENETIC

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

Also known as: collection of blood for NGS and archival tissue sample, where available

benign cardiac lesions; primary cardiac sarcomas

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

control:benign cardiac lesions; case:primary cardiac sarcomas young and adult patients with a diagnosis of a cardiac mass

You may qualify if:

• 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.

You may not qualify if:

• \. Inability of the pa ent to fully understand and sign the informed consent.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

Niguarda Hospital

Milan, Italia, 20262, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

Study Officials

• Katia Bencardino, MD

  Niguarda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia Bencardino, MD

CONTACT

+39026444; katia.bencardino@ospedaleniguarda.it

Giorgio Patelli, MD

CONTACT

+39026444; giorgio.patelli@ospedaleniguarda.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2025
• First Posted: November 19, 2025
• Study Start: July 25, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 25, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

IT (1)