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

Launched by UNIVERSITY OF LEIPZIG · Oct 13, 2022

Keywords

ClinConnect Summary

The PRO-RED study is a clinical trial designed to understand how patients with lower-risk myelodysplastic syndromes (MDS) experience their condition and treatment, particularly regarding their quality of life. The study will follow participants for six months, during which they will receive regular blood transfusions and complete weekly questionnaires through a mobile app or paper forms. These questionnaires will help researchers learn how MDS affects daily life and well-being. Additionally, patients will take photos of their fingernails and eyelids, which researchers will analyze to see if they can use these images to estimate hemoglobin levels—a key measure of blood health.

To be eligible for this study, participants must be diagnosed with lower-risk MDS or related conditions, and they should have needed blood transfusions recently. The study is open to all adults aged 65 to 74, and interested individuals will need to provide written consent to participate. This trial not only aims to gather important information about patient experiences but also hopes to develop new tools that could help monitor blood health using simple images in the future.

Gender

ALL

Eligibility 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