NCT05582902

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Oct 2022

Typical duration for all trials

Geographic Reach
2 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

September 29, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

September 29, 2022

Last Update Submit

April 9, 2026

Conditions

MDSMDS/MPN

Keywords

MDSanemiatransfusion dependencequality of lifeMDS/MPN

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • \- Suspected lack of compliance according to the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

Location

Charité Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Location

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, 01307, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Friedrich-Ebert-Krankenhaus GmbH

Neumünster, 24534, Germany

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 17, 2022

Study Start

October 11, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

AU(1)DE(10)