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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universität Graz Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Medizinische Universität Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| BKH Kufstein Coordinator of this site? Confirm its status | Kufstein | Austria | Not yet recruiting |
| Onkologischer Schwerpunkt am Oskar-Helene-Heim Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Klinikum Garmisch-Partenkirchen Coordinator of this site? Confirm its status | Garmisch-Partenkirchen | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.