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NCT06821880Recruiting

Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational study is to improve the treatment of hematological patients with secondary immunodeficiency (SID) by developing a patient-reported outcome (PRO) instrument to detect clinically diagnosed infections. The study focuses on adults diagnosed with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who are at increased risk of infections due to SID. The main questions it aims to answer are: 1. Can a newly developed PRO screening tool for infection-related symptoms reliably detect infections in patients with SID? 2. How does the health-related quality of life change over the treatment course Participants will: * Complete daily electronic PRO questionnaires (ePRO) to monitor infection-related symptoms * Complete ePRO health-related quality of life questionnaires every 1.5 months * Participate in study visits every three months to ensure documentation of clinical data

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
23 Jan 2025
Start date
3 Feb 2025
Primary completion date
Jul 2026
Lead sponsor
Medical University Innsbruck
NCT number
NCT06821880

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 3 Feb 2025 to the primary completion date, Jul 2026
  • 5 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Adult patient (\>=18 years of age)
  • Access to an internet device (e.g., personal computer or tablet to use a web-based platform, or smartphone where the study app can be installed - all common iOS and Android systems)
  • German-speaking
  • Diagnosis of multiple myeloma or chronic lymphocytic leukemia
  • Secondary immunodeficiency (defined as: recurrent infections, infections requiring inpatient treatment, hypogammaglobulinemia, neutropenia and/or lymphopenia on differential blood cell counts, deficit in lymphocyte subsets as assessed by flow cytometry)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universität Graz
Coordinator of this site? Confirm its status
GrazAustriaNot yet recruiting
Medizinische Universität Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaRecruiting
BKH Kufstein
Coordinator of this site? Confirm its status
KufsteinAustriaNot yet recruiting
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Coordinator of this site? Confirm its status
BerlinGermanyNot yet recruiting
Klinikum Garmisch-Partenkirchen
Coordinator of this site? Confirm its status
Garmisch-PartenkirchenGermanyNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.