Clinical trial NCT05700149: Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma
Official title: Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nodal Marginal Zone Lymphoma
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of NMZL on lymph node histology

Brief 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.

Eligibility 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)

Primary outcomes:
measure: Define and quantify molecular subsets.
timeFrame: Two years: from the end of samples collection to the end of study analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: New York
country: United States
facility: Weill Cornell Medical
state: New York
city: Yerevan
country: Armenia
facility: Hematology Center after Prof. Yeolyan
city: Bari
country: Italy
facility: Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
state: BA
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
state: BG
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
state: BS
city: Pescara
country: Italy
facility: Azienda Sanitaria Locale di Pescara
state: PE
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico
state: PN
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
state: PV
city: Reggio Emilia
country: Italy
facility: AUSL IRCCS di Reggio Emilia, Arcispedale S. Maria Nuova
state: RE
city: Bologna
country: Italy
facility: IRCCS - Azienda Ospedaliero-Universitaria di Bologna
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland and Institute of Oncology Research
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires Genevois
Study officials:
affiliation: Oncology Institute of Southern Switzerland and Institute of Oncology Research
name: Davide Rossi, MD
role: STUDY_CHAIR
References: