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Sample Collection for Systems Evaluation of Patients With Unknown or Incompletely Characterized Immune Defects

NCT04408950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2025-11-19

No results posted yet for this study

Summary

Background:

The immune system defends the body against disease. It has many different parts spread out in

the body, including in the blood and skin. To learn more about it, researchers want to study samples from people with healthy immune systems and people with conditions that affect how the immune system works.

Objective:

To learn about how the different parts of the immune system come together to make a whole.

Eligibility:

People age 2 and older who have a condition that affects the immune system or have a family member with such a condition.

Design:

Participants will be screened with medical and medicine review. Other lab tests may also be reviewed. Some participants will take a pregnancy test.

Participants will give blood samples. They may also give saliva, stool, and urine samples.

A sterile cotton swab may be rubbed over their skin or inside the cheek or nose to collect cells.

If participants have samples collected as part of their regular medical care, their doctor may be asked to send parts of the samples that otherwise would be thrown away. These samples may be from biopsies, endoscopies, or other procedures.

Some participants may have optional skin punch biopsies. For this, their skin is numbed. Then a tool removes 1 or 2 small pieces of skin from the forearm or thigh.

Participants medical records will be checked to see if they have any changes in their health over time. If they have a study visit, they may talk about their medical history and have a physical exam.

Participation lasts 5 years....

Conditions

  • Immunodeficiency

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Irini Sereti, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
2 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2025-01-27
Completion
2025-01-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04408950 on ClinicalTrials.gov