Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain
20 de maio de 2021 atualizado por: Celgene
Prospective Observational Study on Overall Survival and Quality of Life in Patients Older Than 60 Years With Acute Myeloid Leukemia Diagnosis in Spain, Treated According to Standard Clinical Practice
Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of standard clinical practice.
The study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:
- Recruitment period: One year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
- Follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
The patient clinical history and the study´s questionnaires will be the source documents. The study will be carried out in the facilities of the Hematology and Hemotherapy Services of the participating centers, collecting the conditions of medical action according to the standard clinical practice.
Being an observational study, no intervention out of standard clinical practice will be performed. No additional diagnostic or treatment procedures will be applied for the patients.
Tipo de estudo
Observacional
Inscrição (Real)
151
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Madrid, Espanha, 28040
- Fundacion Jimenez Diaz
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Madrid, Espanha, 28006
- Hospital Universitario La Princesa
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Madrid, Espanha, 28034
- Hospital Universitario Ramón y Cajal
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Madrid, Espanha, 28040
- Hospital Clinico San Carlos
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Madrid, Espanha, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Espanha, 28046
- Hospital Universitario La Paz
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Madrid, Espanha, 28222
- Hospital De Fuenlabrada
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Madrid, Espanha, 28905
- Hospital de Getafe
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Andalucía
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Córdoba, Andalucía, Espanha, 14004
- Hospital Univ. Reina Sofia
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Sevilla, Andalucía, Espanha, 41009
- Hospital Universitario Virgen Macarena
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Andalucía/Cádiz
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Jerez, Andalucía/Cádiz, Espanha, 11404
- Hospital de Jerez
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Andalucía/Granada
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Granada, Andalucía/Granada, Espanha, 18014
- Hospital Virgen de las Nieves
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Andalucía/Málaga
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Málaga, Andalucía/Málaga, Espanha, 29010
- Hospital Carlos Haya
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Andalucía/Sevilla
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Sevilla, Andalucía/Sevilla, Espanha, 41013
- Hospital Virgen Del Rocio
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Sevilla, Andalucía/Sevilla, Espanha, 41014
- Hospital Universitario Nuestra Señora de Valme
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Aragón
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Zaragoza, Aragón, Espanha, 50009
- Hospital Clinico Lozano Blesa
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Asturias
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Gijón, Asturias, Espanha, 33394
- Hospital Universitario Cabueñes
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Oviedo, Asturias, Espanha, 33011
- Hospital Universitario Central de Asturias
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Baleares
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Palma de Mallorca, Baleares, Espanha, 07120
- Hospital Son Espases
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Castilla-León
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Burgos, Castilla-León, Espanha, 09006
- Hospital Universitario de Burgos
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León, Castilla-León, Espanha, 24071
- Hospital de Leon
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Salamanca, Castilla-León, Espanha, 37120
- Complejo Hospitalario de Salamanca
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Valladolid, Castilla-León, Espanha, 47003
- Clínico de Valladolid
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Cataluña
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Barcelona, Cataluña, Espanha, 08003
- Hospital del Mar
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Lleida, Cataluña, Espanha, 25198
- Hospital Arnau de Vilanova Lleida
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Manresa, Barcelona, Cataluña, Espanha, 08243
- Hospital de Althaia (H. Sant Juan de Deu de Manresa)
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Comunidad Madrid
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Madrid, Comunidad Madrid, Espanha, 28031
- Hospital Infanta Leonor
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Comunidad Valenciana
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Alicante, Comunidad Valenciana, Espanha, 03010
- Hospital General Alicante
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Valencia, Comunidad Valenciana, Espanha, 46014
- Hospital General Universitario de Valencia
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Extremadura
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Badajoz, Extremadura, Espanha, 06080
- Hospital Infanta Cristina
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Galicia
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La Coruña, Galicia, Espanha, 15006
- Complejo Hospitalario Universitario de A Coruña
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Ourense, Galicia, Espanha, 32005
- Complejo Hospitalario Universitario de Orense
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Islas Canarias
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Las Palmas de Gran Canaria, Islas Canarias, Espanha, 35010
- Hospital Dr. Negrín
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Santa Cruz de Tenerife, Islas Canarias, Espanha, 38010
- Hospital Nuestra Señora de Candelaria
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Santa Cruz de Tenerife, Islas Canarias, Espanha, 38320
- Hospital Universitario Canarias
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Murcia
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Cartagena, Murcia, Murcia, Espanha, 30202
- Hospital Santa Lucía
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Navarra
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Pamplona, Navarra, Navarra, Espanha, 31008
- Complejo Hospitalario de Navarra
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País Vasco
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Bilbao, Vizcaya, País Vasco, Espanha, 48013
- Hospital de Basurto
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San Sebastián, Guipúzcoa, País Vasco, Espanha, 20014
- Hospital Universitario de Donostia
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Vitoria, País Vasco, Espanha, 01009
- Hospital de Txagorritxu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
60 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra de Probabilidade
População do estudo
The study population will consist of approximately 150 patients over 60 with AML diagnosis, defined according to World Health Organization (WHO) 2016 criteria (presence of blasts in the bone marrow or peripheral blood equal to or greater than 20%).
Due to the observational and descriptive nature of the present investigation, the inclusion of a control group is not considered.
Descrição
Inclusion Criteria:
- Patient of both sexes, aged 65 years and older.
- Any race, nationality or socioeconomic status.
- AML (defined according to WHO 2016 criteria de novo, with previous hematological history or secondary.
- Diagnosis date later than 1st November 2017 and later than each center activation date.
- Patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative).
- Having given informed consent prior to start the data collection.
Exclusion Criteria:
- Inability to understand the informed consent form.
- AML previously treated (with or without HSCT).
- Acute promyelocytic leukemia.
- Participation in a clinical trial that includes first-line treatment for AML.
- Do not grant consent.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Patients diagnosed with AML
The study population will consist of approximately 150 patients over 60 with AML diagnosis according to WHO 2016 criteria.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The median survival time in adult patients over 60 with AML diagnosis
Prazo: Up to approximately 12 months
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The overall survival will be calculated, defined as the time from the diagnosis date to the death date from any reason.
In patients who have not died (censored) at the time of data collection, it will be considered the available time to the last control (or last date).
The overall survival will be analyzed using the Kaplan-Meier method, providing the median at 95% CI.
Patients who undergo a hematopoietic transplant will be censored at that time.
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Up to approximately 12 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Overall Survival
Prazo: Up to approximately 12 months
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The Kaplan Meier curve, with the median and the lower and upper limits of the 95% confidence interval, will be reported.
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Up to approximately 12 months
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To describe the socio-demographic and clinical characteristics of patients
Prazo: Up to approximately 12 months
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A description of the study socio-demographic and clinical variables will be made.
The distributions of absolute and relative frequencies of the qualitative variables will be reported, as well as the measures of central and dispersion tendency of the quantitative variables.
A 95% CIs will be obtained for the main variables.
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Up to approximately 12 months
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To describe the disease characteristics
Prazo: Up to approximately 12 months
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A description of the variables that characterize the disease under study will be made.
The distributions of absolute and relative frequencies of the qualitative variables will be reported, as the measures of central tendency and dispersion of the quantitative variables.
A 95% CIs will be obtained for the main variables.
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Up to approximately 12 months
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To describe the front-line treatment strategies
Prazo: Up to approximately 12 months
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The frequency distributions for the first lines of treatment will be presented, as well as the rate distribution of the most frequent treatment sequences and their evolution.
It will be reported the descriptive statistics period of the first treatment lines.
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Up to approximately 12 months
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To assess the HRQOL evolution over time
Prazo: Up to approximately 12 months
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Descriptive statistics will be reported for each of the five dimensions at every period of application of the EQ-5D, so as an overall lineal model of repeated measures for the VAS.
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Up to approximately 12 months
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To evaluate the impact on early mortality
Prazo: Up to approximately 8 weeks
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The t-test will be used to evaluate the impact of the initial leukocyte count on early mortality (dichotomous variable minus death or not in the first 8 weeks).
The stratified analysis with the same approach will be done for treatments that achieve a sufficient sample.
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Up to approximately 8 weeks
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To evaluate the prognostic impact on overall survival
Prazo: Up to approximately 12 months
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A Cox regression model will be made considering the patient survival as a dependent variable and as possible factors the subjective variables (asthenia and HRQOL) at the time of diagnosis, the patient's general condition, and any other clinical variable that is evaluated as possible predictor.
No more than 10 independent variables will be included in the model for theoretical reasons.
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Up to approximately 12 months
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To explore the scales scores to be used as potential predictors tools of treatment tolerability in patients with newly diagnosed AML.
Prazo: Up to approximately 12 months
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The therapeutic approach will be collected according to the investigator clinical judgment, the score of each of the items on the Lee and GAH scales and the treatment administered tolerability assessment according to the score obtained in each scale.
The weighting coefficients will be calculated using a complete multiple linear regression model and a multiple logistic regression.
The optimal cut points for use as a predictive tool for treatment tolerability will be determined by using the ROC curve technique.
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Up to approximately 12 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Montserrat Rafel, RML Advocacy, Celgene
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
28 de fevereiro de 2018
Conclusão Primária (Real)
30 de abril de 2020
Conclusão do estudo (Real)
30 de abril de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
5 de fevereiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de fevereiro de 2018
Primeira postagem (Real)
19 de fevereiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de maio de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de maio de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NDS-AML-001
- U1111-1207-6661 (Identificador de registro: UTN)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .