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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT00047918
Eligibility Criteria:
INCLUSION CRITERIA FOR PATIENTS WITH MASTOCYTOSIS:
Age equal to or greater than 18 years.
Diagnosis of mastocytosis established by presence of typical urticaria pigmentosa skin lesions or a bone marrow biopsy.
Letter of referral from prospective study participant's local doctor.
Ability to give informed consent.
EXCLUSION CRITERIA FOR PATIENTS WITH MASTOCYTOSIS:
Age less than 18 years.
Lack of a referral physician.
Presence of co-morbid conditions which, in the judgment of the investigator or the referring physician, may put the patient at undue risk for travel (such as an acute infection, severe thrombocytopenia).
Inability to provide informed consent.
Inability or refusal to undergo a bone marrow biopsy and aspirate.
Known allergy to latex or Lidocaine.
INCLUSION CRITERIA FOR PATIENTS WITH UNEXPLAINED FLUSHING OR ANAPHYLAXIS:
Age equal to or greater than 18 years.
Presence of flushing or anaphylaxis with negative workup for known causes such as carcinoid syndrome, pheochromocytoma, food allergy.
Ability to give informed consent.
EXCLUSION CRITERIA FOR PATIENTS WITH UNEXPLAINED FLUSHING OR ANAPHYLAXIS:
Same as for patients with mastocytosis.
Known cause for anaphylaxis or flushing.
Frequent life-threatening anaphylactic episodes: History of 6 or more separate attacks resulting in ER visits in the 6 months preceding the referral.
INCLUSION CRITERIA FOR RELATIVE:
To have a first-degree relative accepted to the protocol as a patient with unexplained anaphylaxis, flushing or mastocytosis.
Ability to give informed consent. For minors, ability of the parent to give informed consent.
There are no age restrictions.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00047918
Study Brief:
Protocol Section:
NCT00047918