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RECRUITING
NCT05582902

Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients

Sponsor: University of Leipzig

View on ClinicalTrials.gov

Summary

PRO-RED is a prospective, longitudinal, and multicenter observational study. Enrolled patients will be followed for 6 months in at least monthly intervals in terms of their received red blood cell transfusions and routine myelodysplastic neoplasms (MDS)-associated clinical parameters. In addition, the participating subjects will be provided with a digital/mobile application covering a smartphone app or paper-based questionnaires to answer a set of quality of life (QoL) questions once a week. During routine visits in the clinical trials center performed by the treating physician (at least every month), patients will answer standardized questionnaires for the assessment of MDS-related QoL. Also, included patients will take a photo of fingernails/eyelids with their smartphone camera with the aim to further analyze these pictures in a way to potentially deduct correlated hemoglobin (Hb)-values. As a long term aim beyond the PRO-RED study, the data will serve as a training cohort for the development of an algorithm for image-based calculation of individual Hb levels.

Official title: Longitudinal, App-based Assessment of Varying Red Blood Cell Transfusion Strategies and Their Association With Patient-Reported, Clinical and Economical Outcomes in Lower-risk Myelodysplastic Neoplasms (MDS) Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2022-10-11

Completion Date

2026-06-30

Last Updated

2025-05-14

Healthy Volunteers

No

Conditions

Locations (11)

Universitätsklinik Innsbruck

Innsbruck, Austria

Charité Universitätsmedizin Berlin

Berlin, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Jena

Jena, Germany

University Hospital Leipzig

Leipzig, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Friedrich-Ebert-Krankenhaus GmbH

Neumünster, Germany