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

April 9, 2026 updated by: Anne Sophie Kubasch, University of Leipzig

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik Innsbruck
  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis Hämatologie-Onkologie
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
health-related quality of life
Time Frame: 6 months
health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30
6 months
health-related quality of life
Time Frame: 6 months
health-related quality of life assessed by patient reported questionnaires based on QUALMS
6 months
Course of hemoglobin levels
Time Frame: 6 months
Hemoglobin level measurements at point of care
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche Krebshilfe e.V., Bonn (Germany)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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