Spanish Registry of Patients With IgM Monoclonal Gammopathies
NCT ID: NCT05093153
Last Updated: 2023-08-08
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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UNKNOWN
1000 participants
OBSERVATIONAL
2021-10-01
2025-03-31
Brief Summary
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The aims of this retrospective, observational, multicentric study is:
* To develop a national registry of patients diagnosed with Waldenström's Macroglobulinemia and Monoclonal Gammopathy of uncertain significance -IgM in Spain in the past 30years.
* To evaluate the most relevant clinical characteristics, long-term safety and efficacy of different therapeutic schemes and long-term prognosis of patients with WM
* To help in the design of future therapeutic strategies, risk prognostic factors and clinical trials in Spain.
Methods:
The investigators will collect data from the patient clinical files after prior Informed Consent providing from patients with diagnosis of MGUS-IgM and WM in the past 30 years in Spain, according to the WHO classification of lymphoid tumors (2008) revised in 2016. Data from patients not able to provide IC (i.e., already dead patients) will be included only after the permission of the ethics review board.
The collected data will be included in a database of the Spanish Myeloma and Lymphoma Intergroup (SMALI) team created ad-hoc by the Spanish Society of Hematology and Hemotherapy (SEHH). Each principal investigator in each center will conduct their technical supervision. The evaluation of the treatment protocols will be done following the indications of the intergroup committee according to the guidelines of the International Waldenström's Macroglobulinemia Group.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Waldenström's macroglobulinemia cohort patient
Adult patients diagnosed with Waldenström's Macroglobulinemia
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients having a confirmed diagnosis of either in the las 30 years:
* Monoclonal Gammopathy of uncertain significance -IgM
* Asymptomatic Waldenström's macroglobulinemia
* Symptomatic Waldenström's macroglobulinemia
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fundación Española de Hematología y Hemoterapía
OTHER
Responsible Party
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Locations
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Hospital Son Llatzer
Palma, Balearic Islands, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu de Manresa
Manresa, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
Hospital Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, La Coruña, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
CUN Navarra
Pamplona, Navarre, Spain
Hospital Vital Álvarez-Buylla
Mieres, Principality of Asturias, Spain
Hospital de Galdakao
Galdakao, Vizcaya, Spain
Complejo Hospitalario Universitario de La Coruña (CHUAC)
A Coruña, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Universitario Clínico San Cecilio
Granada, , Spain
CAU de León
León, , Spain
Hospital Universitario Arnau de Vilanova
Lleida, , Spain
Hospital Universitario Fundación Jimenez Diaz
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
CAU de Salamanca
Salamanca, , Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Clínico de Valencia
Valencia, , Spain
Hospital La Fe de Valencia
Valencia, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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Joan Bargay, MD
Role: primary
Albert Pérez Montaña, MD
Role: primary
Laura Abril Sabater, MD
Role: primary
Cristina Motlló, MD
Role: primary
Juan Alfons Soler Campos, MD
Role: primary
Arancha Bermúdez, MD
Role: primary
Marta Sonia Gonzalez, MD
Role: primary
Angela Heredia Cano, MD
Role: primary
María Casanova Espinosa, MD
Role: primary
Miguel Angel Canales Albendea, MD
Role: primary
Francisco Taboada, MD
Role: primary
Garazi Letamendi, MD
Role: primary
Ana Vale López, MD
Role: primary
Carlos Fernandez de Larrea, MD
Role: primary
Eugenia Abella, MD
Role: primary
Mercedes Gironella, MD
Role: primary
Miguel Ángel Álvarez, MD
Role: primary
Isabel García Cabrera, MD
Role: primary
Fernando Escalante, MD
Role: primary
Antonio García Guiñón, MD
Role: primary
Elham Askari, MD
Role: primary
María Belén Navarro Matilla, MD
Role: primary
María Jesús Blanchard, MD
Role: primary
María Alcalá Peña, MD
Role: primary
Ricarda García Sánchez, MD
Role: primary
Ramón García Sanz, MD
Role: primary
Pablo Rios Rull, MD
Role: primary
Ana Saus Carreres, MD
Role: primary
Mario Arnao Herráiz, MD
Role: primary
Paz Rivas, MD
Role: primary
Victoria Dourdil Sahun, MD
Role: primary
Ana Godoy, MD
Role: primary
Other Identifiers
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PRAME
Identifier Type: -
Identifier Source: org_study_id
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