Study Investigating Patient-Reported Outcomes in Lower-risk 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

MDS Anemia Hematologic Diseases Hemic and Lymphatic Diseases MDS/MPN

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Innsbruck, Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

health-related quality of life

Time frame: 6 months

health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30
health-related quality of life

Time frame: 6 months

health-related quality of life assessed by patient reported questionnaires based on QUALMS
Course of hemoglobin levels

Time frame: 6 months

Hemoglobin level measurements at point of care

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

Deutsche Krebshilfe e.V., Bonn (Germany)

Registry information

Official study 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

Acronym: PRO-RED

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Oct 17, 2022
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting