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

Last updated: May 8, 2025
Sponsor: University of Leipzig
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05582902
PRO-RED study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) accordingto World Health Organization (WHO) criteria as determined by microscopic andstandard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC)

  • Symptomatic transfusion dependent (TD) anemia defined as having received ≥3 units ofred blood cells (RBC) within the last 16 weeks prior to screening according to theInternational Working Group (IWG) criteria for MDS (Platzbecker et al. 2019)

Exclusion

Exclusion Criteria:

  • Suspected lack of compliance according to the investigator

Study Design

Total Participants: 60
Study Start date:
October 11, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Universitätsklinik Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 12203
    Germany

    Active - Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Jena

    Jena, 07747
    Germany

    Active - Recruiting

  • University Hospital Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitätsmedizin Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Friedrich-Ebert-Krankenhaus GmbH

    Neumünster, 24534
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.