Clinical trial · Interventional
Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease
Exploratory Analysis of the Molecular Basis of Langerhans and Non-Langerhans Cell Histiocytic Neoplasms and Castleman Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Working on changing study vendor
Summary
Brief summary (as posted)
The purpose of this study is to use agnostic genomic evaluation using whole exome sequencing (WES) of a variety of rare hematologic diseases grouped under rare blood diseases and its variants to further elucidate the understanding of the chemistry of these disorders and identify potential actionable mutations that can be targeted with therapies in the context of clinical trials.
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 |
|---|---|---|---|
| Castleman's Disease (CD) | — | UNRESOLVED | — |
| Langerhans Cell Histiocytosis (LCH) | Langerhans Cell Histiocytosis | ONTOLOGY_EXACT | 0.85 |
| Non-Langerhans-Cell Histiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Genomic analysis
- description
- When a participant's disorder was diagnosed, blood or tissue specimen was collected. A part of the tissue or blood will be sent to an outside company, Tempus, to be tested for specific genetic changes and the results will be sent back to participants' physician.
- interventionNames
- Diagnostic Test: Genetic testing
Primary outcomes (1)
- measure
- Proportion of genomic analyses yielding genetic aberrations
- timeFrame
- Up to 12 months from last participant accrued
- description
- Proportion of genomic analyses yielding actionable genetic aberrations. "Actionable" is defined as a mutation linked to an approved therapy in the particular disease under study or another disease, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have histopathologic confirmation of the particular rare hematologic disease. * Diseases that will be considered as rare hematologic diseases for this study will include the following * Langerhans cell histiocytosis (LCH) * Erdhiem Chester disease (ECD) * Rosai-Dorfman disease (RDD) * Miscellaneous histiocytic entities -indeterminate dendritic cell tumor, interdigitating dendritic cell sarcoma, follicular dendritic cell sarcoma, fibroblastic reticular cell tumor * Unicentric Castleman disease * Multicentric Castleman disease including TAFRO * Follicular Dendritic Cell sarcoma (FDCS) * Newly diagnosed treatment naïve patients as well as patients who received prior therapies (e.g. chemotherapy, targeted therapy, surgery, or radiation) will be included. -Tissue specimens collected within the past 5 yearse will be considered acceptable for study inclusion will include the following * Collected as part of the evaluation for diagnostic confirmation * Tissue specimen or extracted DNA (from blood sample) banked in IRB approved tissue repositories and obtained within five years prior to the date of informed consent. -Tissue samples are planned to be collectedfrom previously stored surgical specimens already being stored in pathology lab * Consent to have germline testing performed in parallel to tumor testingg)Patients willing to receive treatmen Exclusion Criteria: * Life expectancy of less than 6months * Patient unwilling to have germline testing performed on peripheral blood or buccal mucosa
References
Publications (0)
Data not yet available