| NCT ID | NCT03206099 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Atopy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2017-07-31 |
| Primary Completion | 2042-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2017-07-31 with a primary completion date of 2042-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems. Objective: To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol. Eligibility: Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children's National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives Design: Researchers will study participant's DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant's DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people. Participants will receive results that: * Are important to their health * Have been confirmed in a clinical lab * Suggest that they could be at risk for serious disease that may affect your current or future medical management. Some genetic information we return to participants may be of uncertain importance. If genetic test results are unrelated to the participant's NIH evaluations, then we will not typically report: * Normal variants * Information about progressive, fatal conditions that have no effective treatment * Carrier status (conditions you don t have but could pass on) The samples and data will be saved for future research. Personal data will be kept as private as possible. If future studies need new information, participants may be contacted.
Eligibility Criteria
* INCLUSION CRITERIA: * Must fulfill one of the following criteria: * Proband participants: must be individuals under investigation by another NIH protocol on which they are co-enrolled, or are referred from the GDMCC protocol "Defining the Genetic Etiology of Suppurative Lung Disease in Children and Adults" (NCT04702243) or "Use of Tiered Genetic Sequencing and Specialty Referral for Identifying and Managing Rare Genetic Causes of Chronic Suppurative Respiratory Disease" (External study #: 26-1761). Probands may have a disease under investigation or be healthy volunteers. * Biological relatives: biologically related to a proband participant. * Aged 0-99 years. * Participants must be willing to undergo genetic testing. * Participants must be willing to allow samples to be stored for future research. * Participants must be willing to have their de-identified genomic data shared, for example in a controlled access databases like the Database of Genotypes and Phenotypes (dbGaP). * To complete surveys and interviews: * Proficient with the English language. * Able to provide informed consent. * Adult healthy volunteers must be able to provide informed consent. EXCLUSION CRITERIA: Any condition that, in the opinion of the investigator, contraindicates participation in this study is a reason for exclusion.
Contact & Investigator
Morgan N Similuk
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT03206099 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 100 Years, studying Atopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03206099 currently recruiting?
Yes, NCT03206099 is actively recruiting participants. Contact the research team at morgan.similuk@nih.gov for enrollment information.
Where is the NCT03206099 trial being conducted?
This trial is being conducted at Washington D.C., United States, Bethesda, United States.
Who is sponsoring the NCT03206099 clinical trial?
NCT03206099 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Morgan N Similuk at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 20,000 participants.