RECRUITING

Studies of Disorders With Increased Susceptibility to Fungal Infections

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: \- Researchers are interested in studying disorders that make individuals more susceptible to fungal infections, specifically infections with the Candida yeast. These disorders are often related to problems with the immune system and may have genetic factors, which suggests that researchers should study not only the individual with the disorder, but also his or her first- and second-degree relatives (such as parents, siblings, children, and first cousins). To provide material for future research, individuals with immune disorders and their first- and second-degree relatives will be asked to provide blood and other samples for testing and comparison with samples taken from healthy volunteers with no history of immune disorders. Objectives: \- To collect blood and other biological samples to study immune disorders that make individuals more susceptible to fungal infections. Eligibility: * Individuals of any age who have abnormal immune function characterized by recurrent or unusual fungal infections, recurrent or chronic inflammation, or other types of immune dysfunction. * First- or second-degree genetically related family members (limited to mother, father, siblings, grandparents, children, aunts, uncles, and first cousins). * Healthy volunteers at least 18 years of age (for comparison purposes). Design: * Participants will provide blood samples and buccal (cells from the inside of the mouth near the cheek) samples. * Participants with immune disorders will also be asked to provide urine samples, saliva or mucosal samples, or skin tissue biopsies, and may also have imaging studies (such as x-rays) to collect information for research. * Samples may be collected at the National Institutes of Health or at other clinical locations for the samples to the sent to the National Institutes of Health. * No treatment will be provided as part of this protocol.

Official Title

Studies of Disorders With Increased Susceptibility to Fungal Infections

Quick Facts

Study Start:2011-01-07
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01222741

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:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be 2 years of age to be seen at the Clinical Center as an outpatient. Children \<=3 years of age must not have severe infections, as assessed by the investigator, to be seen at the Clinical Center. Send-in samples may be submitted by participants \>30 days of age.
  2. * Have an abnormality of immune function as manifested by recurrent or unusual fungal infections, recurrent or chronic inflammation, or previous laboratory evidence of immune dysfunction. Of particular focus of this study are patients with:
  3. * APECED
  4. * CMC
  5. * MPO
  6. * IPEX
  7. * Hyper-immunoglobulin E syndrome (Job s syndrome)
  8. * CGD
  9. * Biotinidase deficiency
  10. * IKAROS defects
  11. * AIOLOS defects
  12. * IRF4 defects
  13. * Other conditions showing increased susceptibility to such infections as described in infants and type 1 diabetic patients
  14. * Have a primary physician outside of the NIH.
  15. * Agree to have blood stored for future research.
  16. * Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
  17. * Be 2 years of age to be seen at the Clinical Center as an outpatient. Children \<=3 years of age must not have severe infections, as assessed by the investigator, to be seen at the Clinical Center. Send-in samples may be submitted for participants \>30 days of age.
  18. * Be a mother, father, sibling, child, grandparent, aunt, uncle, or first cousin to a patient participant.
  19. * Adult relatives must be able to provide informed consent.
  20. * Agree to have blood stored for future research.
  21. * Be 18 to 85 years old.
  22. * Have a hemoglobin count of \>11 g/dL.
  23. * Weigh \>=110 pounds.
  24. * Be able to provide informed consent.
  25. * Be willing to have blood stored for future research.
  1. * Is receiving chemotherapeutic agent(s) or has an underlying malignancy.
  2. * Is pregnant.
  3. * Has a history of heart, lung, or kidney disease, or bleeding disorders.
  4. * Has HIV or viral hepatitis (B or C), or history of viral hepatitis B or C since age 11.

Contacts and Locations

Study Contact

Sergio D Rosenzweig, M.D.
CONTACT
(301) 451-8971
srosenzweig@mail.nih.gov

Principal Investigator

Sergio D Rosenzweig, 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)

  • Sergio D Rosenzweig, 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 Date2011-01-07
Study Completion DateN/A

Study Record Updates

Study Start Date2011-01-07
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • PID
  • Primary Immune Deficiencies
  • Candida
  • Immune Abnormalities
  • Diabetic
  • Natural History

Additional Relevant MeSH Terms

  • Fungal Infections
  • Primary Immune Deficiencies