Trial Title:
Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma
NCT ID:
NCT05700149
Condition:
Nodal Marginal Zone Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
International retrospective observational cohort study aimed to describe a molecular
classification for NMZL.
Detailed description:
Already existing and coded tumor biological material and health-related patient data will
be retrospectively collected from institutional biobanks and patients' charts or
electronic medical records upon receipt of ethical approval. Each patient enrolled in the
study will be assigned to a unique identification numerical code upon registration in the
study. The unique identification code will be used to record health-related data and to
label biological samples. The coded biological material will be transferred to the
coordinating center at the Oncology Institute of Southern Switzerland and Institute of
Oncology Research in Bellinzona. Health-related data will be collected in the eCRF
(OpenClinica). Data quality will be insured by query generation.
Annotated baseline features will include date of diagnosis, date of lymph node biopsy,
age, gender, ECOG PS, Ann Arbor stage, LDH, number and location of extranodal sites, bone
marrow involvement and percentage, peripheral blood involvement, number of nodal sites, B
symptoms, lymph nodes larger than 7 cm, Hb, platelets, lymphocytes, beta-2-microglobulin,
albumin, HCV infection, serum paraprotein and type.
Annotated follow-up features included date of progression to a disease requiring
treatment, type of first line treatment, date of start of first line treatment, date of
progression after first line treatment, date of second line treatment, type of second
line treatment, date of transformation, date of death, cause of death, date of last
follow-up.
Mutation analysis, immunoglobulin gene rearrangement analysis, copy number aberration
analysis, structural variant analysis and DNA methylation profile will be performed by
next generation sequencing of genomic DNA extracted from the lymph node biopsy. Gene
expression will be assessed by next generation sequencing of RNA extracted from the lymph
node biopsy.
Criteria for eligibility:
Study pop:
Patients with diagnosis of NMZL on lymph node histology
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Male or female adults 18 years or older
2. Diagnosis of NMZL on lymph node histology after Jan 1st, 2000
3. Availability of tumor material from lymph node (either frozen or FFPE) collected
when the patient was treatment naïve
4. Availability of the baseline and follow-up annotations
Exclusion Criteria:
1. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by
carefully evaluating the extranodal tissues draining to the involved lymph nodes by
imaging or endoscopy)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Chapman, MD
Investigator:
Last name:
Jennifer Chapman, MD
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medical
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Giorgio Inghirami, MD
Investigator:
Last name:
Giorgio Inghirami, MD
Email:
Principal Investigator
Facility:
Name:
Hematology Center after Prof. Yeolyan
Address:
City:
Yerevan
Country:
Armenia
Status:
Not yet recruiting
Contact:
Last name:
Armine Farmazyan, MD
Investigator:
Last name:
Armine Farmazyan
Email:
Principal Investigator
Facility:
Name:
Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carla Minoia, MD
Investigator:
Last name:
Carla Minoia, MD
Email:
Principal Investigator
Facility:
Name:
ASST Papa Giovanni XXIII
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Rambaldi, MD
Investigator:
Last name:
Alessandro Rambaldi, MD
Email:
Principal Investigator
Facility:
Name:
ASST degli Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandra Tucci, MD
Investigator:
Last name:
Alessandra Tucci, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Locale di Pescara
Address:
City:
Pescara
Zip:
65124
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elsa Pennese, MD
Investigator:
Last name:
Elsa Pennese, MD
Email:
Principal Investigator
Facility:
Name:
Centro di Riferimento Oncologico
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Spina, MD
Investigator:
Last name:
Michele Spina, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Arcaini, MD
Investigator:
Last name:
Luca Arcaini, MD
Email:
Principal Investigator
Facility:
Name:
AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Stefano Luminari, MD
Investigator:
Last name:
Stefano Luminari, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS - Azienda Ospedaliero-Universitaria di Bologna
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Pier Luigi Zinzani, MD
Investigator:
Last name:
Pier Luigi Zinzani, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Federico II
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Severino, MD
Investigator:
Last name:
Alessandro Severino, MD
Email:
Principal Investigator
Facility:
Name:
AOU Maggiore della Carità
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Gianluca Gaidano, MD
Investigator:
Last name:
Gianluca Gaidano, MD
Email:
Principal Investigator
Facility:
Name:
University Hospital Basel
Address:
City:
Basel
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Alexandar Tzankov, MD
Investigator:
Last name:
Alexandar Tzankov
Email:
Principal Investigator
Facility:
Name:
Oncology Institute of Southern Switzerland and Institute of Oncology Research
Address:
City:
Bellinzona
Zip:
6500
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Maria Cristina Pirosa, MD
Investigator:
Last name:
Maria Cristina Pirosa, MD
Email:
Principal Investigator
Facility:
Name:
Hôpitaux Universitaires Genevois
Address:
City:
Genève
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Noémie Lang, MD
Investigator:
Last name:
Noémie Lang
Email:
Principal Investigator
Start date:
December 31, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
International Extranodal Lymphoma Study Group (IELSG)
Agency class:
Other
Source:
International Extranodal Lymphoma Study Group (IELSG)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05700149
