Enrolling by invitation

Inflammatory Disorders Evaluation and Long-Term Follow-Up

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Study AimThis study aims to observe and follow up with patients who have unusual inflammatory disorders, and screen them for potential inclusion in other research protocols.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Inflammation

Over 2 Years

See all eligibility criteria

How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: June 1993

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1993Actual date on which the first participant was enrolled.

This study focuses on understanding and monitoring patients with acute or chronic inflammatory disorders. These disorders can be caused by various infections or immune system responses. The aim is to gather a group of patients whose conditions do not fit into other specific research studies, allowing for a broader understanding of these diseases. This research is crucial because it could lead to better ways to monitor and treat inflammatory issues, and it helps identify family members who might also be affected. The outcomes of this study could improve how these conditions are managed and pave the way for future research. Participants in this study will undergo thorough clinical evaluations and continuous monitoring, which is more detailed than usual care. This involves collecting samples for laboratory studies to gain insights into inflammatory conditions. The study also serves as a screening process, helping to identify patients who might be suitable for other specific research protocols. This approach ensures a comprehensive understanding of each patient's condition and may lead to improved treatment options in the future.

Official TitleEvaluation and Long-Term Follow-Up of Patients With Acute or Chronic Inflammatory Disorders 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: August 14, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
500 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other
Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 2 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Inflammation
Criteria

* INCLUSION CRITIERIA: * Males and females ages 2 years and older. * Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders, as determined by the principal or associated investigators. * A NIAID/LCIM investigator has an interest in the patient s illness and is willing to serve as attending physician to supervise the patient's medical care at the NIH. * If appropriate, immediate family members of patients with inflammatory conditions may be evaluated under this protocol to determine if they may also be affected by their relative s disease. * Willingness to participate in clinical protocols when appropriate. * Subjects must maintain a primary physician outside NIH for non-protocol related medical complaints and for emergency medical treatment required for these or other of their disorders. * Willingness to have samples stored and to provide tissue samples for studying immune dysregulation and for genetic analysis. * Ablility to provide informed consent or, for the patient cohort, has a designated legally authorized representative (LAR). * For females, not pregnant.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
immediate family members of patients with inflammatory conditions may be evaluated under this protocol
Group II
Inflammatory conditions associated with, but not limited, to acute and chronic infections or presumed infections, and congenital or acquired immunologic disorders
Study Objectives
Primary Objectives

screening of patients for other protocols,

evaluation and follow-up of interesting patients, who do not fit in our other protocols

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Institutes of Health Clinical CenterBethesda, United StatesSee the location
Enrolling by invitationOne Study Center