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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02417766
Eligibility Criteria:
* INCLUSION CRITERIA:
Whole Exome Sequencing with Secondary Findings Disclosure
The following inclusion criteria apply to all research participants on this protocol:
1. Age 0-100 years old. Clinical evaluation at the NIHCC requires age \>2 years. Affected relatives \<2 years of age may be included in genetic family studies despite the fact that he/she is too young for evaluation at the clinical center. Including affected relatives in family-based whole exome sequencing is critically important, even if the study team has to rely only on medical records because NIHCC evaluation is not permitted due to age.
2. Willingness to allow sharing of genetic information in shared controlled access databases like dbGaP.
3. Willingness to receive secondary finding report.
Probands (i.e., affected individuals serving as the starting point for genetic study of a family) must have:
1. Primary enrollment on a NIH Institutional Review Board (IRB) approved protocol (e.g., 05-I-0213 or 93-I-0063), which will execute the majority of clinical and research evaluations.
2. A suspected genetic basis for the presenting immune disorder with features including but not limited to autoimmunity, autoinflammatory conditions, lymphadenopathy, end-organ dysfunction, unusual infections, allergies, or laboratory abnormalities consistent with immune dysregulation that has not been previously identified and/or with a family history suggesting genetically-based immune dysfunction (e.g., similar phenotypes among relatives and/or consanguinity).
EXCLUSION CRITERIA:
Any participant can be excluded for the following:
1\. Any condition which in the opinion of the investigator may interfere with the research that is the focus of this protocol.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02417766
Study Brief:
Protocol Section:
NCT02417766