Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00276757
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histopathologically confirmed diagnosis of Langerhans cell histiocytosis according to the criteria defined by the Histiocyte Society
* Demonstration of CD1a antigenic determinants on the surface of lesional cells (by immunocytology or immunohistology) or Birbeck granules in lesional cells by electron microscopy
* Considered at risk or low risk according to the following criteria:
* Multi-system at risk disease, defined as involvement of one or more risk organs (i.e., hematopoietic system, liver, spleen, or lungs)
* No single-system lung involvement
* Multi-system low-risk disease
* Multiple organs involved but without involvement of risk organs
* Single-system disease
* Multifocal bone disease (i.e., lesions in 2 or more different bones)
* Localized special site involvement, such as CNS-risk lesions with intracranial soft tissue extension or vertebral lesions with intraspinal soft tissue extension
* Vault lesions are not regarded as CNS-risk lesions
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No prior treatment for Langerhans cell histiocytosis
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT00276757
Study Brief:
Protocol Section:
NCT00276757