Trial Title:
Primary Cardiac Lymphoma: Italian Multicenter Experience
NCT ID:
NCT05819528
Condition:
Primary Cardiac Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
PCL
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
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.
Detailed description:
Primary cardiac lymphoma (PCL), an extranodal lymphoma involving only the heart (with
possible involvement of the pericardium) is a rare entity, accounting for 2% of primary
cardiac tumors and 0.5% of extranodal lymphomas. It is more frequent in males; clinical
presentation is predominated by cardiac symptoms. The most common histology is Diffuse
Large B Cell Lymphoma (DLBCL). Being DLBCL the most frequent histology, patients are
usually treated with R-CHOP (rituximab - cyclophosphamide, doxorubicin, vincristine and
prednisone) or R-CHOP-like chemoimmunotherapy regimens, with an historically poor
outcome, although in the last years survival rates significantly increased. Due to the
rarity of this condition, isolated case reports and a few reviews have been published so
far, that in most cases included a population collected in a wide period of time,
heterogeneously managed both in terms of treatments received and follow-up, and who often
did not strictly respect the criteria of PCL. Indeed, while some aspects of PCL are
well-known, especially the ones concerning its clinical presentation, a few topics
deserve more in-depth analysis. The rationale of this study is to provide an overview on
PCL 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.
Criteria for eligibility:
Study pop:
Patient affected by primary cardiac lymphoma from 1st January 2000 to 31st December 2020.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Address:
City:
Pagani
Zip:
84016
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Catello Califano, MD
Email:
c.califano@aslsalerno.it
Investigator:
Last name:
Catello Califano, MD
Email:
Principal Investigator
Facility:
Name:
AOU di Sassari - Ematologia
Address:
City:
Sassari
Zip:
07100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Claudio Fozza, MD
Email:
cfozza@uniss.it
Investigator:
Last name:
Claudio Fozza, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Address:
City:
Trieste
Zip:
34121
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Elisa Lucchini, MD
Email:
elisa.lucchini@asugi.sanita.fvg.it
Investigator:
Last name:
Elisa Lucchini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Dell'angelo - U.O. Ematologia
Address:
City:
Mestre
Zip:
30174
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Cristina Skert, MD
Email:
cristina.skert@aulss3.veneto.it
Investigator:
Last name:
Cristina Skert, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giuseppe Gritti, MD
Email:
g.gritti@asst-pg23.it
Investigator:
Last name:
Giuseppe Gritti, MD
Email:
Principal Investigator
Facility:
Name:
ASST Spedali Civili di Brescia - Ematologia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Rosa Daffini, MD
Email:
rosadaffini@yahoo.it
Investigator:
Last name:
Rosa Daffini, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione
Address:
City:
Ferrara
Zip:
44124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Mariarosaria Sessa, MD
Email:
sessamariarosaria@gmail.com
Investigator:
Last name:
Mariarosaria Sessa, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Andrés JM Ferreri, MD
Email:
andres.ferreri@hsr.it
Investigator:
Last name:
Andrés JM Ferreri, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Anna Guidetti, MD
Email:
anna.guidetti@istitutotumori.mi.it
Investigator:
Last name:
Anna Guidetti, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Erika Ravelli, MD
Email:
erika.ravelli@ospedaleniguarda.it
Investigator:
Last name:
Erika Ravelli, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale S. Maria della Misericordia - Ematologia
Address:
City:
Perugia
Zip:
06129
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Leonardo Flenghi, MD
Email:
leonardo.flenghi@ospedale.perugia.it
Investigator:
Last name:
Leonardo Flenghi, MD
Email:
Principal Investigator
Facility:
Name:
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Address:
City:
Pescara
Zip:
65124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elsa Pennese, MD
Email:
elsa.pennese@asl.pe.it
Investigator:
Last name:
Elsa Pennese, MD
Email:
Principal Investigator
Facility:
Name:
AOU Pisana - U.O. Ematologia
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Galimberti, MD
Email:
sara.galimberti@med.unipi.it
Investigator:
Last name:
Sara Galimberti, MD
Email:
Principal Investigator
Facility:
Name:
Roma - Universitа Cattolica S. Cuore - Ematologia
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Stefan Hohaus, MD
Email:
stefan.hohaus@unicatt.it
Investigator:
Last name:
Stefan Hohaus, MD
Email:
Principal Investigator
Facility:
Name:
AO Sant'Andrea - Ematologia
Address:
City:
Roma
Zip:
00183
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Agostino Tafuri, MD
Email:
agostino.tafuri@ospedalesantandrea.it
Investigator:
Last name:
Agostino Tafuri, MD
Email:
Principal Investigator
Facility:
Name:
A.O. S. Maria di Terni - S.C. Oncoematologia
Address:
City:
Terni
Zip:
05100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Anna Marina Liberati, MD
Email:
marina.liberati@unipg.it
Investigator:
Last name:
Anna Marina Liberati, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federica Cavallo, MD
Email:
f.cavallo@unito.it
Investigator:
Last name:
Federica Cavallo, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Ca Foncello - S.C di Ematologia
Address:
City:
Treviso
Zip:
31100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elisabetta Scarpa, MD
Email:
elisabetta.scarpa@aulss2.veneto.it
Investigator:
Last name:
Elisabetta Scarpa, MD
Email:
Principal Investigator
Facility:
Name:
AOU Integrata di Verona - U.O. Ematologia
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Isacco Ferrarini, MD
Email:
isacco.ferrarini@univr.it
Investigator:
Last name:
Isacco Ferrarini, MD
Email:
Principal Investigator
Start date:
September 2024
Completion date:
March 2025
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05819528
