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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT06078969
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of Langerhans cell histiocytosis (LCH) of bone;
* Single-system involvement (skeletal system);
* No need of surgical intervention;
* Must be able to swallow tablets;
* Signing informed consent form.
Exclusion Criteria:
* Multi-system involvements (≥2 systems, including bone, liver, spleen, hematologic system, central nerve system);
* Need of surgical intervention (e.g. pathological fracture and/or spinal cord compression)
* Glucocorticoid allergy;
* Immunodeficiency;
* Severe infection;
* Insulin dependent/independent Diabetes;
* Having taken glucocorticoid in the past two weeks;
* Not capable of swallowing tablets;
* Without signed informed consent inform.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT06078969
Study Brief:
Protocol Section:
NCT06078969