Clinical Trials in Italy / NCT05819528
Recruiting
Observational
Primary Cardiac Lymphoma: Italian Multicenter Experience
NCT05819528 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Primary Cardiac Lymphoma
Study summary
The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.
Eligibility
Inclusion Criteria:
* Diagnosis of PCL (any histotype) defined as an extranodal lymphoma involving only the heart with possible involvement of the pericardium.
* Age ≥18 years.
* Diagnosis histologically confirmed. Cytofluorimetry analysis of pericardial fluid showing phenotypic features consistent with a primary cardiac lymphoma is permitted if a biopsy sample is not feasible/available for diagnosis; monoclonality is not accepted as a surrogate for diagnosis.
* Date of diagnosis: from 1st January 2000 to 31st December 2020.
* Only patients treated in first-line with chemoimmunotherapy regimens including an anti-CD20 monoclonal antibody are eligible for the study.
* Signed written informed consent (in case of unreachable subject please see chapter 11.2)
Exclusion Criteria:
* Secondary cardiac involvement from lymphoma; primary mediastinal lymphoma with pericardial infiltration or other lymphomas with involvement of the pericardium/the heart by contiguity and primary effusion lymphoma are not included in this study.
* Patients treated with chemotherapy regimens that did not include an anti-CD20 monoclonal antibody as first-line therapy.
* Refuse to sign a written informed consent
Primary outcome measure(s)
- Overall survival (OS) — The endpoint will be evaluated within 2 months from the end of data collection. The end of data collection is scheduled within the Q4 (fourth quarter) of 2023.
Overall survival, the percentage of patients alive of the cohort (patients with cardiac lymphoma diagnosed from 01/01/2000 to 31/12/2020).
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Azienda Ospedaliera Papa Giovanni XXIII - Ematologia | Bergamo | Bergamo | Recruiting |
| ASST Spedali Civili di Brescia - Ematologia | Brescia | Brescia | Recruiting |
| Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione | Ferrara | Ferrara | Recruiting |
| Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia | Milan | Milano | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia | Milan | Milano | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia | Milan | Milano | Recruiting |
| Ospedale S. Maria della Misericordia - Ematologia | Perugia | Perugia | Recruiting |
| AOU Pisana - U.O. Ematologia | Pisa | Pisa | Not Yet Recruiting |
| AO Sant'Andrea - Ematologia | Roma | Roma | Recruiting |
| AOU di Sassari - Ematologia | Sassari | SS | Recruiting |
| A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria | Torino | Torino | Not Yet Recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia | Trieste | TS | Recruiting |
| AOU Integrata di Verona - U.O. Ematologia | Verona | Verona | Recruiting |
More Fondazione Italiana Linfomi - ETS trials in Italy
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05819528 on ClinicalTrials.gov ↗ ← All trials in Italy