Clinical trial · Observational
Histiocytic Disorder Follow-up Study
NCT05915208CI-TRIAL-00114662recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erdheim-Chester Disease | Erdheim-Chester Disease | ONTOLOGY_EXACT | 0.98 |
| Histiocytosis | — | UNRESOLVED | — |
| Langerhans Cell Histiocytosis | Langerhans Cell Histiocytosis | ONTOLOGY_EXACT | 0.90 |
| Malignant Histiocytoses | — | UNRESOLVED | — |
| Rosai Dorfman Disease | Rosai-Dorfman-Destombes Disease | ALIAS | 0.90 |
| Xanthogranuloma | Xanthogranuloma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Chronic health conditions diagnosed after LCH diagnosis graded using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0 (https://ctep.cancer.gov)
- timeFrame
- From diagnosis of histiocytic disorder to age at completion of survey, assessed up to 200 months
- description
- The CTCAE criteria for CHCs distinguishes each acute and chronic condition (including SPMs) in persons with cancer from grades 1 through 4 with unique clinical descriptions of severity (grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening/disabling). The main outcome will be the number of distinct CTCAE grade 3-4 conditions among LCH cases compared with unaffected (non-cancer) controls.
- measure
- All-cause and cause-specific mortality
- timeFrame
- 2 years preceding death
- description
- Causes of death will be grouped into primary cancer (LCH)-related mortality (PCRM) and non-primary cancer-related mortality (NPCRM - death from all causes other than the index LCH diagnosis) by two independent investigators.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of histiocytic disorder at any age 1. Langerhans cell histiocytosis, 2. Erdheim-Chester disease, 3. Rosai-Dorfman disease, 4. Xanthogranuloma, 5. Mixed histiocytosis 6. Malignant histiocytosis (Histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma) 7. Hemophagocytic lymphohistiocytosis Exclusion Criteria: * None
References
Publications (0)
Data not yet available
No reference posted for this study.