The protocol will be carried out in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the following United States Code of Federal Regulations (CFR) applicable to clinical studies: 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812.
NIH-funded investigators and study site staff who are responsible for the conduct, management, or oversight of NIH-funded studies have completed Human Subjects Protection and ICH GCP Training.
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be approved by the IRB; an IRB determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Have cryptococcosis as determined by information collected from their medical records, telephone interviews, or from a referring physician:
✓. Be over the age of 18 years old.
✓. Have a primary physician outside of the NIH.
✓. Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
✓. Allow samples to be stored for future research.
✓. Pregnant patients will not be excluded. However, research procedures greater than minimal risk including bone marrow biopsy and apheresis would not be performed on pregnant subjects. Otherwise, pregnant patients with cryptococcus would be treated with as per standard of care, minimizing teratogenic potential of drugs and ionizing radiation whenever possible.
✓. Be a genetic relative of a patient enrolled in this study
✓. Be over the age of 18 years old
Exclusion criteria
What they're measuring
1
Characterize the full spectrum of clinical disease of Cryptococcosis in previously healthy adults without known immune predisposition.
Timeframe: 1-5 years
Trial details
NCT IDNCT00001352
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. The presence of certain types of acquired abnormalities of immunity due to:
✕. Any condition that in the opinion of the investigator may interfere with the evaluation of a co-existing abnormality of immunity that is the subject of study under this protocol. For example, we may exclude patients with Cushing s disease that have very high cortisol levels at the time of diagnosis of their cryptococcosis.
✕Any condition that in the opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol.
✕. HIV or viral hepatitis (B or C).
✕. History of recurrent or severe infections.
✕. History of intravenous drug use.
✕. History of engaging in high-risk activities for exposure to HIV.
✕. Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy.