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Malignant and rheumatic diseases - two extremes of a dysregulated immune system Registry-based observation and investigation of linkages and interdependencies between malignant and rheumatic diseases (RheuMal-, TRheuMa- and ParaRheuMa-registry)

Malignant and rheumatic diseases - two extremes of a dysregulated immune system Registry-based observation and investigation of linkages and interdependencies between malignant and rheumatic diseases (RheuMal-, TRheuMa- and ParaRheuMa-registry) - MalheuR Project

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036681
Enrollment
500
Registered
2025-04-16
Start date
2018-08-03
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C00-D48 M05-M14 M30-M36 M45 M46 M60 M65 L40.5

Interventions

Group 1: Retrospective and prospective observation of routine care according to established clinical standards of cases (patients suffering from concomitant rheumatic disease / toxicities and malignan

Sponsors

Universitätsklinikum Heidelberg, Innere Medizin V
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • RheuMal (Rheumatologic patients with malignancy): patients suffering from concomitant rheumatic disease and malignancy and/or premalignant conditions. • TRheuMa (Therapy-induced rheumatic symptoms in patients with malignancy): patients suffering from rheumatic symptoms as a result of checkpoint inhibitors or other cancer therapies. • ParaRheuMa (Paraneoplastic rheumatic symptoms in patients with malignancy): patients suffering from paraneoplastic rheumatic symptoms due to a malignancy. • Control group: Matched patients suffering from either a malignant or a rheumatic disease at risk for developing the other disease entity / symptom complex. • Informed consent obtained

Exclusion criteria

Exclusion criteria: • Inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Identification of linkages and interdependencies between malignant and rheumatic diseases from three different dimensions: -RheuMal (Rheumatologic patients with malignancy): Coincidence of rheumatic diseases with certain tumor entities and interrelationship between immunosuppressive therapy regimes and risk of malignancy / relapse. -TRheuMa (Therapy-induced rheumatic symptoms in patients with malignancy): systematic overview of the incidence, prevalence, characteristics and outcome of side effects of antineoplastic therapy regimes with focus on immune-related adverse events (irAEs) triggered by checkpoint-inhibitors. -ParaRheuMa (Paraneoplastic rheumatic symptoms in patients with malignancy): Correlation of paraneoplastic symptom complexes with certain tumor entities.

Secondary

MeasureTime frame
• Cover and characterize the entire spectrum of possible malignant and rheumatic diseases. • Gather data on individual disease course and outcome to expand the knowledge base on clinical management. • Correlate data with established registries for patients with malignant or rheumatic disease. • Case-control approach with matched patients at risk to verify hypotheses on individual risk factors for developing malignancy or rheumatic symptom complexes as side effects of certain antineoplastic therapy regimes. • Collaboration with existing immunologic and biobank projects to correlate clinical and serological parameters and identify novel biomarkers and therapeutic targets.

Countries

Germany

Contacts

Public ContactKarolina Gente

Universitätsklinikum Heidelberg, Innere Medizin V

malheur.MED5@med.uni-heidelberg.de+49 6221 56 8030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026