Investigating patient-reported outcomes in lower-risk MDS patients
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
This study is trying to see how living with lower-risk myelodysplastic syndromes affects patients' quality of life and transfusion needs over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 11 sites (Innsbruck and 10 other locations) |
| Trial ID | NCT05582902 on ClinicalTrials.gov |
What this trial studies
PRO-RED is a prospective, longitudinal, multicenter observational study that follows patients with lower-risk myelodysplastic neoplasms (MDS) for six months. Participants will report their quality of life and transfusion needs through a digital application or paper questionnaires on a weekly basis. Monthly clinical visits will include standardized assessments of MDS-related quality of life and the collection of photos of fingernails and eyelids to analyze potential correlations with hemoglobin levels. The data collected will also serve as a training cohort for future analyses.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with lower-risk MDS or MDS/MPN overlap who are symptomatic and transfusion dependent.
Not a fit: Patients who do not have a confirmed diagnosis of lower-risk MDS or are not transfusion dependent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of quality of life in lower-risk MDS patients and improve management strategies.
How similar studies have performed: Other studies have shown success in utilizing patient-reported outcomes to improve understanding of MDS, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Innsbruck and 10 other locations
- Universitätsklinik Innsbruck — Innsbruck, Austria (Recruiting)
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Klinikum Chemnitz gGmbH — Chemnitz, Germany (Recruiting)
- Gemeinschaftspraxis Hämatologie-Onkologie — Dresden, Germany (Recruiting)
- Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden — Dresden, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Jena — Jena, Germany (Recruiting)
- University Hospital Leipzig — Leipzig, Germany (Recruiting)
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz, Germany (Recruiting)
- Universitätsmedizin Mannheim — Mannheim, Germany (Recruiting)
- Friedrich-Ebert-Krankenhaus GmbH — Neumünster, Germany (Recruiting)
Study contacts
- Study coordinator: Beatrice Berneck, PhD
- Email: Beatrice.Berneck@medizin.uni-leipzig.de
- Phone: +49 341 13203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.