Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03610802
Status
Recruiting
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Conditions

  • Primary Immunodeficiency

Eligibility Criteria

Sex
ALL
Age
1 Day - 99 Years
Healthy Volunteers
Not accepted

Study Details

Background: The immune system helps the body fight infections. Primary immunodeficiency disorders (PIDs) are diseases that make it easier for people to get sick. Many PIDs are inherited. This means parents can pass them on to their children. Knowing what causes a person s PID is important to decide what treatment to give them. Objective: To test samples from people with a PID or people related to someone with a PID to find out what causes PIDs. Eligibility: People ages 99 or younger who have a PID or have a relative with a PID Design: Participants will be screened with a medical history over the phone. They may need to give permission for researchers talk to their doctors about their health. Their relatives may be contacted to see if they want to join the study. Participants will give samples. These could be: Blood: Participants blood will be taken from a vein in an arm, or with a prick on the finger or heel for children. Saliva, urine, or stool: Participants will provide each sample in a special cup. Nose or cheek swab: Participants will rub the skin inside their nose or cheek using a cotton swab. Cord blood: If participants have a baby during the study, blood will be collected from the baby s umbilical cord after it is born. Samples from medical procedures: If, during the study, the participants have a medical procedure that collects samples, the samples may be used for the study.

Key Dates

Start date
Jul 22, 2019
Status verified
Mar 2026
Primary completion
Mar 31, 2038
Completion
Mar 31, 2038

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Biological relatives
    Biological relative (mother, father, siblings, children, grandparents, aunts, uncles, or first cousins) of patient, with no clinical evidence of having a PID.
  • Arm: Patients
    Patients with PID, which may be defined by laboratory and/or clinical findings on 2 or more occasions that are consistent with a defect in innate or adaptive immunity.

Primary Outcome Measure

Identification of patients with abnormalities of the immune system that may be enrolled in other NIH protocols [ Time Frame: Duration of participant enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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