RECRUITING

Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Immune system and nervous system have significant interaction so that People with immunity diseases can have complications that affect the nervous system and people with some neurological disease may have defects in their immune system.These complications can affect many body functions, including how they move, walk, think, and feel. Researchers do not fully understand how immune diseases affect the nervous system. By learning more, they hope to create more effective treatments. Objective: To learn more about the interaction between immune and nervous system and how immunity disease affect the nervous system. Eligibility: People aged 2 years and older with an immunity disease. Their healthy biological relatives and other healthy volunteers are also needed. Design: Participants will be screened. Blood will be drawn for research. They may have imaging scans. Adults may undergo lumbar puncture: A needle will be inserted into their back to collect fluid from the space around the spinal cord. The imaging scans and lumbar puncture will be optional for healthy relatives and volunteers. All participants will have 1 study visit per year for 5 years. They will be asked to donate samples of body fluids at each visit. Blood samples are required for the study. All other donations are optional. These may include saliva, urine, breast milk, stool, vaginal secretions, and wound drainage. Affected participants may be asked for a skin biopsy: A small sample of skin will be removed. They may also be photographed or videotaped to record the symptoms of their disease. Tests for each study visit may be spread over several days, if needed. Visits may be at the clinic. Participants may also collect their own samples at home and send them to the researchers....

Official Title

Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity

Quick Facts

Study Start:2024-01-12
Study Completion:2043-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06169150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged \>=2 years. To be seen at the NIH CC, participants must be \>=3 years of age.
  2. 2. Willing to allow specimens and data to be stored for future research.
  3. 3. Willing to allow genetic testing on their biospecimens.
  4. 4. Able to provide informed consent (for ages \>=18 years) or has parent(s) or guardian(s) who can provide permission to participate on their behalf (for ages \<18 years).
  5. * Decisionally impaired affected adult participants may have a legally authorized representative (LAR) to provide informed consent on their behalf.
  6. 1. Any neurologic symptoms accompanied by CSF with evidence of inflammation (which may include pleocytosis, hypoglycorrachia, elevated protein, or other evidence of intrathecal immune activation, including immunoglobulin \[Ig\] G index or presence of oligoclonal bands).
  7. 2. Systemic infection or inflammatory disease with neurologic involvement.
  8. 3. Neuroimaging suggestive of infection or inflammation (for example, presence of contrast-enhancing lesions on CT or MRI).
  9. 4. Clinical presentation suggestive of infection or inflammatory process of the nervous system without better explanation.
  10. 5. History of infection or inflammatory process of the nervous system.
  11. 1. Is either a biological relative of an affected participant or is unrelated.
  12. 2. Does not have a known diagnosis of neuroinfectious disease or neuroinflammation.
  1. 1. Pregnant (for biological relatives and healthy volunteers).
  2. 2. Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.

Contacts and Locations

Study Contact

Kelsey L Yoo, P.A.-C
CONTACT
(240) 656-0596
kelsey.yoo@nih.gov
Farinaz Safavi, M.D.
CONTACT
(301) 496-4952
farinaz.safavi@nih.gov

Principal Investigator

Farinaz Safavi, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Farinaz Safavi, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-12
Study Completion Date2043-10-01

Study Record Updates

Study Start Date2024-01-12
Study Completion Date2043-10-01

Terms related to this study

Keywords Provided by Researchers

  • Errors Of Immunity
  • Neurological Diseases
  • Neuroinflammation
  • Neuroinfections
  • Neurodegeneration
  • Primary Immunodeficiency
  • Neuropathogenesis
  • Inborn Errors of Immunity

Additional Relevant MeSH Terms

  • Nervous System Disease
  • Immune System Disease