Evaluation of Patients With Immune Function Abnormalities

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 9, 2005

Keywords

ClinConnect Summary

This clinical trial is examining patients with immune function problems that lead to frequent infections or ongoing inflammation. These issues may stem from inherited conditions like chronic granulomatous disease (CGD) and X-linked severe combined immunodeficiency (XSCID), or from conditions caused by treatments like graft-versus-host disease (GVHD). The goal of the study is to better understand these diseases and help develop new treatments. Participants may be observed for up to one year, and the information gathered could also help determine eligibility for other clinical studies.

To join the trial, patients must be at least 2 years old and show signs of immune dysfunction, like unusual infections or inflammation. Family members of patients, including parents, siblings, and grandparents, can also participate. Healthy volunteers between 18 and 85 years old are welcome as well. Participants can expect a thorough medical history review, physical exams, and various tests, including blood and urine samples, to study their immune function. For those with immune issues, follow-up visits will occur at six months and one year to monitor their health and any treatments they may receive. It’s important to note that pregnant women and individuals with certain medical conditions may not be eligible for the study.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• Patients:
• To be eligible to participate in this study as a patient, an individual must meet the following criteria:
• • Must be 2 years of age to be seen at the Clinical Center as an outpatient and they must not have any active infections. Send-in samples for clinical diagnosis at any age.
• * Have an abnormality of immune function as manifested by:
• • recurrent or unusual infections,
• • recurrent or chronic inflammation, or
• • previous laboratory evidence of immune dysfunction.
• • Have a primary physician outside of the NIH.
• Relatives of Patient:
• To be eligible to participate in this study as a patient relative, an individual must meet the following criteria:
• • Be a biological mother, father, sibling, child, grandparent, aunt, uncle, or first cousin to a patient.
• • --Sibling, child, first cousin, aunt, and uncle must be 2 years of age to be seen at the Clinical Center as an outpatient with no active infections, Send-in samples for clinical diagnosis at any age.
• • Be willing to have blood stored for future studies and/or other research purposes.
• Healthy Volunteers:
• To be eligible to participate in this study as a healthy volunteer, an individual must meet the following criteria:
• • Be a healthy adult of either sex and between age of 18 and 85 years old.
• • Have a hemoglobin count of \>=11.
• • Weight greater than 110 pounds.
• • Not have a history of intravenous injection drug use.
• • Not have a history of engaging in high-risk activities for exposure to HIV.
• • Be willing to have their blood samples stored for future research and modified to iPS cells.
• EXCLUSION CRITERIA:
• Patients and Relatives of Patient:
• • In general, there are no strict exclusion criteria for these cohorts. However, the presence of certain types of acquired abnormalities of immunity solely due to HIV, chemotherapeutic agent(s), or an underlying malignancy could be grounds for possible exclusion for a patient or relative of a patient. In the opinion of the investigator, the presence of such disease processes may interfere with evaluation of a co-existing abnormality of immunity that is the subject of study under this protocol. Pregnant females will not be allowed to participate in any procedure that may be dangerous to the pregnancy or the fetus.
• Healthy Volunteers:
• An individual who meets any of the following criteria will be excluded from participation as a healthy volunteer in this study:
• • Have HIV or viral hepatitis (B or C), or history of viral hepatitis B or C since age 11.
• • Receiving chemotherapeutic agent(s) or have underlying malignancy.
• • Pregnant.
• • Have history of heart, lung, kidney disease, or bleeding disorders.