Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-05-17 @ 11:59 AM
Study NCT ID:
NCT05582902
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2022-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'health-related quality of life', 'timeFrame': '6 months', 'description': 'health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30'}, {'measure': 'health-related quality of life', 'timeFrame': '6 months', 'description': 'health-related quality of life assessed by patient reported questionnaires based on QUALMS'}, {'measure': 'Course of hemoglobin levels', 'timeFrame': '6 months', 'description': 'Hemoglobin level measurements at point of care'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDS', 'anemia', 'transfusion dependence', 'quality of life', 'MDS/MPN'], 'conditions': ['MDS', 'MDS/MPN']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from lower-risk myelodysplastic neoplasms (MDS) or MDS/MPN with red blood cell transfusion-dependent anemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* 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)\n* 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)\n\nExclusion Criteria:\n\n\\- Suspected lack of compliance according to the investigator'}, 'identificationModule': {'nctId': 'NCT05582902', 'acronym': 'PRO-RED', 'briefTitle': 'Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PRO-RED study'}}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Dominik Wolf, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinik Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kathrin Rieger, Dr.', 'role': 'CONTACT'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '09116', 'city': 'Chemnitz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mathias Hänel, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Klinikum Chemnitz gGmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Illmer, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Gemeinschaftspraxis Hämatologie-Onkologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Katja Sockel, Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ulrich Germing, Prof.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '07747', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Olaposi Yomade, Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Beatrice Berneck, Dr.', 'role': 'CONTACT'}], 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Sasca, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Nowak, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Universitätsmedizin Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '24534', 'city': 'Neumünster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Mahlmann, Dr.', 'role': 'CONTACT'}], 'facility': 'Friedrich-Ebert-Krankenhaus GmbH', 'geoPoint': {'lat': 54.07399, 'lon': 9.98456}}], 'centralContacts': [{'name': 'Beatrice Berneck, PhD', 'role': 'CONTACT', 'email': 'Beatrice.Berneck@medizin.uni-leipzig.de', 'phone': '+49 341 13203'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anne Sophie Kubasch', 'investigatorAffiliation': 'University of Leipzig'}}}}