Clinical Trial

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

Study acronym: PRO-RED
Active, Not Recruiting
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Record status
This record was last updated April 14, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2022-10-13; most recent amendment 2026-04-09.
Status change: Recruiting → Active, Not Recruiting 2026-04-09
Trial Details
NCT Number NCT05582902
Lead Sponsor University of Leipzig
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions MDS, MDS/MPN
Enrollment 60 participants
Start Date 2022-10-11
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-14