Donnerstag, 2. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
PRO-RED

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

Rekrutierend

NCT-Nummer:
NCT05582902

Studienbeginn:
Oktober 2022

Letztes Update:
19.04.2024

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Leipzig

Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)

Kontakt

Beatrice Berneck, PhD
Kontakt:
Phone: +49 341 12457153
E-Mail: Beatrice.Berneck@medizin.uni-leipzig.de» Kontaktdaten anzeigen

Studienlocations
(3 von 11)

Alle anzeigen

Studien-Informationen

Brief 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. health-related quality of life (Time Frame - 6 months):
health-related quality of life assessed by patient reported questionnaires based on EORTC QLQ-C30

2. health-related quality of life (Time Frame - 6 months):
health-related quality of life assessed by patient reported questionnaires based on QUALMS

3. Course of hemoglobin levels (Time Frame - 6 months):
Hemoglobin level measurements at point of care

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.