Studying the genes and biology of tumors in people with neuroblastoma
Studies blood, bone marrow and tumor samples from children and young people with neuroblastoma.
Plain-language title generated from the registry record
Registry title: Prospective Multicenter Study of the Genomic, Transcriptomic, and Biological Profile of Patients With Neuroblastoma
Key facts
- Where
- Ancona, Bari, Bergamo, Bologna, Brescia, Cagliari, Catania, Catanzaro, Cosenza, Ferrara, Florence, Genova, Milan, Modena, Naples, Padova, Palermo, Parma, Pavia, Perugia, Pescara, Pisa, Reggio Calabria, Rimini, Roma, San Giovanni Rotondo, Sassari, Siena, Torino, Trieste, and Verona, ItalySee the 35 sites
Where in Italy
- Azienda Ospedali Riuniti Presidio "G. Salesi", SOS Oncoematologia pediatricaAncona, ItalyTaking people
- AO Policlinico, Dipartimento di pediatriaBari, ItalyTaking people
- Ospedale Papa Giovanni XXIII USS Oncoematologia PediatricBergamo, ItalyTaking people
- Oncologia ed Ematologia Pediatrica "Lalla Seragnoli" Clinica Pediatrica Policlinico Sant'Orsola MalpighiBologna, ItalyTaking people
- Spedali civili, presidio Ospedale dei Bambini oncoematologia pediatrica e TMOBrescia, ItalyTaking people
- SC Oncoematologia Pediatrica e Patologia della Coagulazione, Ospedale Pediatrico Microcitemico "Antonio Cao", Azienda Ospedaliera BrotzuCagliari, ItalyTaking people
- AOU Policlinico Vittorio Emanuele, UOC Ematologia ed oncologia pediatrica con TMOCatania, ItalyTaking people
- AO Pugliese-Ciaccio, UOC di Ematologia ed Oncologia PediatricCatanzaro, ItalyTaking people
- SO "Annunziata" UOC PediatriaCosenza, ItalyTaking people
- AOU Sant'Anna di Ferrara, SSD Oncoematologia PediatricFerrara, ItalyTaking people
- A.O.U Meyer Centro di Eccellenza Oncologia ed Ematologia pediatrica - SOC Oncologia, Ematologia e Trapianto di Cellule Staminali EmopoieticheFlorence, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenova, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Fondazione IRCCS Istituto Nazionale Tumori SC Pediatria OncologicaMilan, ItalyTaking people
- Azienda Policlinico di Modena UO Pediatria ad indirizzo oncoematologicoModena, ItalyTaking people
- AORN Santobono-Pausilipon, Dipartimento di OncoematologiaNaples, ItalyTaking people
- Università degli Studi della Campania "Luigi Vanvitelli" UOSD Ematologie e Oncologia Pediatrica DAI Materno infantileNaples, ItalyTaking people
- Azienda Ospedaliera di Padova - Oncoematologia PediatricaPadova, ItalyTaking people
- ARNAS Civico di Cristina e Benfratelli - UOC Oncoematologia PediatricaPalermo, ItalyTaking people
- Azienda Ospedaliero Universitaria di Parma, UOC di Pediatria ed OncoematologiaParma, ItalyTaking people
- Fondazione Irccs, Policlinico San Matteo, SC Oncoematologia pediatricaPavia, ItalyTaking people
- Ospedale 'S.M. della Misericordia'. A.O. Perugia S.C. di Oncoematologia Pediatrica con Trapianto di CSEPerugia, ItalyTaking people
- Ospedale Civile dello Spirito Santo, Diaprtimento di ematologia, medicina trasfusionale e biotecnologiePescara, ItalyTaking people
- Ospedale S. Chiara, AOU Pisana, UO Oncoematologia pediatricaPisa, ItalyTaking people
- AO "Bianchi Melacrino Morelli", UOC EmatologiaReggio Calabria, ItalyTaking people
- Ospedale Infermi U.O. di Pediatria SS Oncoematologia pediatricaRimini, ItalyTaking people
- IRCCS Ospedale Pediatrico Bambino Gesu, Dip.to Ematologia Oncologia e medicina trasfusionaleRoma, ItalyTaking people
- Policlinico Gemelli, UOC Oncologia PediatricaRoma, ItalyTaking people
- Policlinico Umberto I, Universita' "la Sapienza" UOC Oncoematologia pediatricaRoma, ItalyTaking people
- IRCCS Ospedale "Casa Sollievo Della Sofferenza", UOC Oncoematologia pediatricaSan Giovanni Rotondo, ItalyTaking people
- AOU Sassari, Clinica PediatricaSassari, ItalyTaking people
- Policlinico "Le Scotte", clinica pediatricaSiena, ItalyTaking people
- AOU Citta' della Salute e della scienza di Torino, Presidio Infantile Regina Margherita, SC Oncoematologia Pediatrica e centro TrapiantiTorino, ItalyTaking people
- IRCCS Materno Infantile "Burlo Garofolo" , Dipartimento pediatrico SC Oncoematologia pediatrica ed SS Trapianto di midolloTrieste, ItalyTaking people
- Policlinico 'G.B. Rossi - AOUI Verona, U.O.C Oncoematologia PediatricaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Giannina Gaslini
- Trial code
- NCT07881172
- Record updated
- 19 October 2026
- Original description
This is an investigator-initiated, multicenter, prospective, non-profit study.Read full original descriptionShow less
Protocollo Multicentrico Prospettico Studio Del Profilo Genomico, Trascrittomico e Biologico in Pazienti Affetti da Neuroblastoma / Prospective Multicenter Study of the Genomic, Transcriptomic, and Biological Profile of Patients With Neuroblastoma
This is an investigator-initiated, multicenter, prospective, non-profit study.
Patients who provide informed consent to participate will be asked to provide a peripheral blood sample, a fresh tumor tissue sample (obtained by biopsy), and/or a bone marrow sample.
All patients with neuroblastoma at diagnosis, with relapsed disease, or with refractory disease may participate, provided that the diagnosis and disease status are established by the treating physician in accordance with national clinical practice and by the participating study center.
Enrolled patients will be reported and registered by means of a paper-based notification form sent by email to the Coordinating Center, which will assign a unique identification code to each patient.
At the time of notification, clinical and treatment-related data will be collected using a paper-based Case Report Form (CRF).
Biological material (peripheral blood, bone marrow, and/or tumor biopsy samples) must be centralized at the Laboratory of Experimental Oncology Therapies, IRCCS Istituto Giannina Gaslini, Genoa, Italy, in accordance with the procedures described in the study protocol. Samples will be processed and analyzed as specified in the protocol.
The results of the initial analysis performed at CEINGE, Naples, will be communicated by the CEINGE Laboratory to the Coordinating Center. A multidisciplinary meeting will then be held with a panel of experts, including oncologists, biologists, pharmacists, and infectious disease specialists. Following this meeting, an individual report will be prepared for each patient.
The report will include the results of Whole Exome Sequencing (WES) or Cancer Gene Panel (CGP) analysis performed on the patient's DNA, together with any potential therapeutic recommendations based on the molecular alterations identified. The report will be sent to the physician responsible for the individual patient.
For patients who provide additional consent by signing the appropriate informed consent form, biological material may also be used for the following purposes:
i) Immunophenotyping, with particular focus on GD2 and B7-H3 expression in tumor biopsy samples and in neuroblastoma cells infiltrating the bone marrow;
ii) High-throughput screening of libraries comprising readily available anticancer drugs;
iii) Generation of in vitro and in vivo tumor models, including primary cell lines and spheroids in vitro, and murine models such as Patient-Derived Xenografts (PDX) and Cell Patient-Derived Xenografts (CPDX) at the Coordinating Center, as well as zebrafish models at San Martino-IST, Genoa, and/or Città della Speranza, Padua.
Inclusion: All patients diagnosed with neuroblastoma at AIEOP centers; Signed informed consent/assent provided by the subject and/or their parents or legal guardians; Age 0 to ≤ 31 years; Life expectancy > 3 months; Availability of fresh tumor tissue and/or bone marrow and peripheral blood samples.
Exclusion: Absence of signed informed consent/assent from the subject and/or their parents or legal guardians; Life expectancy < 3 months.