Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
370 participants
OBSERVATIONAL
2011-09-30
2024-12-31
Brief Summary
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Detailed Description
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The study is aimed to verify whether a prognostic collection of data would allow the development of a more accurate prognostic assessment for non-follicular low grade B-cell lymphomas.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Training and validation cohort
One cohort: from this cohort 2/3 of patients will be randomly separated after registration in training sample, to develop a prognostic model, and 1/3 in test sample, to validate the prognostic score obtained from the prognostic model.
The training cohort aims to develop a prognostic model and a resulting score, on the basis of clinical, biochemical and blood count parameters, in patients with non-follicular indolent lymphomas.
Intervention: any treatment, watch and wait policy included
The validation cohort is aims to assess the prognostic score on a collected set of data in parallel but independently of the "sample training".
Intervention: any treatment, watch and wait policy included
Any treatment, watch and wait policy included
Patients registered in the study despite their planned treatment, watch and wait policy included. The "planned treatment" mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes.
Interventions
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Any treatment, watch and wait policy included
Patients registered in the study despite their planned treatment, watch and wait policy included. The "planned treatment" mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes.
Eligibility Criteria
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Inclusion Criteria
* Splenic MZL (bone marrow histology and/or spleen tissue)
* Extranodal MZL of MALT (tissue biopsy)
* Nodal MZL (lymph node biopsy)
* Lymphocytic lymphoma (lymph node biopsy)
* Lymphoplasmacytic lymphoma (bone marrow histology or lymph node biopsy)
* CD5-negative low grade B-cell lymphoma (bone marrow histology)
2. Age over 18
3. Written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Arcaini Luca, MD
Role: STUDY_CHAIR
Divisione di Ematologia IRCCS Policlinico S. Matteo Pavia
Locations
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Vienna Univ Med Int I
Vienna, , Austria
Center of Hematology and Hemotherapy, UNICAMP, University of Campinas
Campinas, , Brazil
Universidade Federal Do Rio de Janeiro
Rio de Janeiro, , Brazil
São Paulo-Santa Casa Medical School
São Paulo, , Brazil
Hospital Saint-Louis
Paris, , France
UO Oncoematologia Ospedale Umberto I
Pagani, Salerno, Italy
Oncologia Medica A - Centro di Riferimento Oncologico
Aviano (PN), , Italy
UO Ematologia con Trapianto Policlinico Consorziale
Bari, , Italy
USC Ematologia Ospedali Riuniti di Bergamo
Bergamo, , Italy
Ematologia e CTMO Ospedale Businco
Cagliari, , Italy
UOC Ematologia, Azienda Ospedaliera Garibaldi P.O. Nesima
Catania, , Italy
US Oncoematologia- Ospedale Valduce
Como, , Italy
Unità Operativa Complessa di Ematologia - AO di Cosenza
Cosenza, , Italy
UO Ematologia, PO Vito Fazzi
Lecce, , Italy
Ematologia Ospedale Madonna delle Grazie
Matera, , Italy
SC. Ematologia. Osp. Riuniti Papardo Piemonte
Messina, , Italy
Dipartimento di Oncoematologia Ospedale San Raffaele
Milan, , Italy
SC Ematologia AO Niguarda Ca' Granda
Milan, , Italy
UO Ematologia, AO San Carlo Borromeo
Milan, , Italy
UO Oncologia Medica, Ospedale San Paolo
Milan, , Italy
UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
Modena, , Italy
Clinica Ematologica AO San Gerardo di Monza
Monza, , Italy
SCDU Ematologia - AOU Ospedale Maggiore
Novara, , Italy
Istituto Oncologico Veneto IRCCS
Padua, , Italy
Ematologia e CTMO Ospedale Maggiore di Parma
Parma, , Italy
Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, , Italy
Dipartimento di Ematologia Ospedale Civile Spirito Santo Pescara
Pescara, , Italy
UO Ematologia AOU S. Chiara Pisa
Pisa, , Italy
Divisione di Ematologia - Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
SC Ematologia Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
UO Ematologia e Trapianto Cellule Staminali, IRCCS, Centro di riferimento Oncologico di Basilicata
Rionero in Vulture, , Italy
Ematologia Università Campus Biomedico
Roma, , Italy
Ematologia Università Roma La Sapienza
Roma, , Italy
UOSD DH Ematologia Ospedale San Eugenio
Roma, , Italy
Dipartimento di Oncologia Medica ed Ematologia Istituto Humanitas
Rozzano (MI), , Italy
UOC Medicina Interna MO DH Oncologico
Sassuolo, , Italy
UOC Ematologia, AOU Senese
Siena, , Italy
Ematologia PO SG Moscati
Taranto, , Italy
SC Oncoematologia con autotrapianto AO S. Maria Terni
Terni, , Italy
SC Ematologia Universitaria, AO Città della Salute e della Scienza
Torino, , Italy
SC Ematologia, AO Città della Salute e della Scienza
Torino, , Italy
Unità operativa Complessa Ematologia - Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Divisione di Ematologia, Ospedale San Bortolo
Vicenza, , Italy
LISBOA-IPO "Francisco Gentil"
Lisbon, , Portugal
National Cancer Institute of Health Ukraine
Kiev, , Ukraine
Countries
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References
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Luminari S, Merli M, Rattotti S, Tarantino V, Marcheselli L, Cavallo F, Varettoni M, Bianchi B, Merli F, Tedeschi A, Cabras G, Re F, Visco C, Torresan Delamain M, Cencini E, Spina M, Ferrero S, Ferrari A, Deodato M, Mannina D, Annibali O, Rago A, Orsucci L, Defrancesco I, Frigeni M, Cesaretti M, Arcaini L. Early progression as a predictor of survival in marginal zone lymphomas: an analysis from the FIL-NF10 study. Blood. 2019 Sep 5;134(10):798-801. doi: 10.1182/blood.2019001088. Epub 2019 Jul 10.
Other Identifiers
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NF2010
Identifier Type: -
Identifier Source: org_study_id
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