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

MDS Clinical Trial

— PRO-RED  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582902
• Other study ID #: PRO-RED study
• Status: Recruiting
• Start date: October 11, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University of Leipzig
• Contact: Beatrice Berneck, PhD
• Phone: +49 341 12457153
• Email: Beatrice.Berneck[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MDS
• MDS/MPN

Locations

Country	Name	City	State
Austria	Universitätsklinik Innsbruck	Innsbruck
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Jena	Jena
Germany	University Hospital Leipzig	Leipzig
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Friedrich-Ebert-Krankenhaus GmbH	Neumünster

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Deutsche Krebshilfe e.V., Bonn (Germany)

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health-related quality of life	health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30	6 months
Primary	health-related quality of life	health-related quality of life assessed by patient reported questionnaires based on QUALMS	6 months
Primary	Course of hemoglobin levels	Hemoglobin level measurements at point of care	6 months