NCT06821880 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
| NCT ID | NCT06821880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Chronic Lymphocytic Leukaemia (CLL) |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-02-03 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06821880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukaemia (CLL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06821880 currently recruiting?
Yes, NCT06821880 is actively recruiting participants. Contact the research team at jens.lehmann@i-med.ac.at for enrollment information.
Where is the NCT06821880 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Graz, Austria, Kufstein, Austria, Berlin, Germany and 1 additional location.
Who is sponsoring the NCT06821880 clinical trial?
NCT06821880 is sponsored by Medical University Innsbruck. The trial plans to enroll 120 participants.