Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients (PRO-RED)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: MDS; MDS/MPN

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Universitatsklinik Innsbruck
• Germany
  • Berlin, Germany, 12203
    • Charité Universitätsmedizin Berlin
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz Ggmbh
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
  • Dresden, Germany, 01307
    • Gemeinschaftspraxis Hämatologie-Onkologie
  • Düsseldorf, Germany, 40225
    • Universitatsklinikum Dusseldorf
  • Jena, Germany, 07747
    • Universitätsklinikum Jena
  • Leipzig, Germany, 04103
    • University Hospital Leipzig
  • Mainz, Germany, 55131
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68167
    • Universitätsmedizin Mannheim
  • Neumünster, Germany, 24534
    • Friedrich-Ebert-Krankenhaus GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from lower-risk myelodysplastic neoplasms (MDS) or MDS/MPN with red blood cell transfusion-dependent anemia

Description

Inclusion Criteria:

• Written informed consent
• Confirmed diagnosis of lower-risk myelodysplastic neoplasms (MDS; IPSS-R very low, low, intermediate up to 3.5 points) or MDS/MPN overlap including MDS/MPN-RS-T, MDS/MPNu, aCML or non-proliferative chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO) criteria as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC)
• Symptomatic transfusion dependent (TD) anemia defined as having received ≥3 units of red blood cells (RBC) within the last 16 weeks prior to screening according to the International Working Group (IWG) criteria for MDS (Platzbecker et al. 2019)

Exclusion Criteria:

- Suspected lack of compliance according to the investigator

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
health-related quality of life	health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30	6 months
health-related quality of life	health-related quality of life assessed by patient reported questionnaires based on QUALMS	6 months
Course of hemoglobin levels	Hemoglobin level measurements at point of care	6 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; anemia; MDS; MDS/MPN; transfusion dependence
• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia
• Other Study ID Numbers: PRO-RED study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No