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:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT00050193
Eligibility Criteria:
* INCLUSION CRITERIA:
Children with tissue-diagnosed pediatric-onset mastocytosis formerly enrolled in protocols 90-I-0120, and 93-I-0136 or per physician referral with more severe disease as indicated by one of the following parameters:
* Hepatomegaly or splenomegaly;
* Diffuse cutaneous mastocytosis;
* History of gastrointestinal bleeding or peptic ulcer disease;
* Bone marrow biopsy with abnormal numbers or shaped mast cells or abnormal flow cytometry;
* Serum tryptase greater than 20ng/ml;
* Hematologic abnormalities such as an increase WBC, thrombocytosis, and/or an increase in PT and/or PTT.
INCLUSION CRITERIA-SUBJECT:
* Age birth to 21.0 years of age at the time of entry into the protocol
* Diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy
* Subject has a primary medical care provider outside the NIH
* Subject or parent or guardian is able to give informed consent
INCLUSION CRITERIA-RELATIVE:
* A biological relative with or without the diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy
* Subject has a primary medical care provider outside the NIH
EXCLUSION CRITERIA SUBJECT:
* Age greater than or equal to 21.0 years
* No primary care physician
* Has AIDS or is HIV Positive
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00050193
Study Brief:
Protocol Section:
NCT00050193