Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Secondary Immunodeficiency (SID) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with MM or CLL at risk of infectious complications due to SID
Primary outcomes (1)
- measure
- Diagnostic accuracy of the ePRO monitoring instrument for infection-related symptoms
- timeFrame
- From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first
- description
- Evaluation of diagnostic accuracy of the daily ePRO screening measure to detect infections as diagnosed by a clinician (CTCAE).
Secondary outcomes (3)
- measure
- Changes in health-related quality of life measured with the EORTC QLQ-C30
- timeFrame
- From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first
- description
- Changes in health-related quality of life over the study period (from inclusion to six and 12 months) measured with the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDLehmann J, Bohn JP, Seidl C, Vorbach SM, Willenbacher W, Holzner B, Schuler M. Study protocol for developing a patient-reported outcome measure for infection screening in hematological patients with secondary immunodeficiency. BMC Cancer. 2025 Oct 16;25(1):1664. doi: 10.1186/s12885-025-14996-y. PMID 41162921