Trial Title:
Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients
NCT ID:
NCT05582902
Condition:
MDS
MDS/MPN
Conditions: Keywords:
MDS
anemia
transfusion dependence
quality of life
MDS/MPN
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients suffering from lower-risk myelodysplastic neoplasms (MDS) or MDS/MPN with red
blood cell transfusion-dependent anemia
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitätsklinik Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Dominik Wolf, Prof. Dr.
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
12203
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Kathrin Rieger, Dr.
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mathias Hänel, PD Dr.
Facility:
Name:
Gemeinschaftspraxis Hämatologie-Onkologie
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Illmer, PD Dr.
Facility:
Name:
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Katja Sockel, Dr.
Facility:
Name:
Universitätsklinikum Düsseldorf
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Ulrich Germing, Prof.
Facility:
Name:
Universitätsklinikum Jena
Address:
City:
Jena
Zip:
07747
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Olaposi Yomade, Dr.
Facility:
Name:
University Hospital Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Beatrice Berneck, Dr.
Facility:
Name:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Address:
City:
Mainz
Zip:
55131
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniel Sasca, Dr. med.
Facility:
Name:
Universitätsmedizin Mannheim
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniel Nowak, Prof. Dr.
Facility:
Name:
Friedrich-Ebert-Krankenhaus GmbH
Address:
City:
Neumünster
Zip:
24534
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Stefan Mahlmann, Dr.
Start date:
October 11, 2022
Completion date:
March 31, 2025
Lead sponsor:
Agency:
University of Leipzig
Agency class:
Other
Collaborator:
Agency:
Deutsche Krebshilfe e.V., Bonn (Germany)
Agency class:
Other
Source:
University of Leipzig
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05582902
