NCT03435341

Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 151 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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: 1. 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). 2. 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.

Conditions

• Leukemia, Myeloid, Acute

Timeline

• Start date: 2018-02-28
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-02-19
• Last updated: 2021-05-21

Locations

40 sites across 1 country: Spain