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

NCT ID: NCT05582902

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-11

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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MDS MDS/MPN

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Anne Sophie Kubasch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinik Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status RECRUITING

Gemeinschaftspraxis Hämatologie-Onkologie

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status RECRUITING

Universitätsklinikum Jena

Jena, , Germany

Site Status RECRUITING

University Hospital Leipzig

Leipzig, , Germany

Site Status RECRUITING

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status RECRUITING

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status RECRUITING

Friedrich-Ebert-Krankenhaus GmbH

Neumünster, , Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Beatrice Berneck, PhD

Role: CONTACT

+49 341 13203

Facility Contacts

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Dominik Wolf, Prof. Dr.

Role: primary

Kathrin Rieger, Dr.

Role: primary

Mathias Hänel, PD Dr.

Role: primary

Thomas Illmer, PD Dr.

Role: primary

Katja Sockel, Dr.

Role: primary

Ulrich Germing, Prof.

Role: primary

Olaposi Yomade, Dr.

Role: primary

Beatrice Berneck, Dr.

Role: primary

Daniel Sasca, Dr. med.

Role: primary

Daniel Nowak, Prof. Dr.

Role: primary

Stefan Mahlmann, Dr.

Role: primary

Other Identifiers

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PRO-RED study

Identifier Type: -

Identifier Source: org_study_id

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