💬In plain words
What the trial is, and whether it could suit you
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 a
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* INCLUSION CRITERIA:
Patients
Patients must:
1. Have cryptococcosis as determined by information collected from their medical records, telephone interviews, or from a referring physician:
* histopathology showing cryptococci; or
* culture of C. neoformans or C. gattii
* a positive cryptococcal antigen in the serum and/or CSF, together with CSF cell count and chemistry consistent with cryptococcal meningitis.
2. Be over the age of 18 years old.
3. Have a primary physician outside of the NIH.
4. Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
5. Allow samples to be stored for future research.
6. 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.
Blood Relatives of Patients
Blood relatives must:
1. Be a genetic relative of a patient enrolled in this study
2. Be over the age of 18 years old
3. Agree to undergo genetic testing that may include WES and high density SNP analysis
4. Allow samples to be stored for future research
Healthy Volunteers
Healthy volunteers must:
1. Be between the ages of 18 and 70 years old
2. Allow samples to be stored for future research
EXCLUSION CRITERIA:
Patients
Patients will be excluded for any of the following:
1. The presence of certain types of acquired abnormalities of immunity due to:
* HIV
* Cancer chemotherapeutic agent(s)
* An underlying malignancy could be grounds for possible exclusion of a patient if, in the opinion of the investigator, the underlying disease predisposed the patient to the infection
* Monoclonal antibody therapy directed against a patient s immune system
2. 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.
Genetic Relatives of Patients
Genetic relatives will be excluded for the following:
-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.
Healthy Volunteers
Healthy volunteers will be excluded for any of the following:
1. HIV or viral hepatitis (B or C).
2. History of recurrent or severe infections.
3. History of intravenous drug use.
4. History of engaging in high-risk activities for exposure to HIV.
5. Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy.
6. Pregnancy.
7. Have history of heart, lung, kidney disease, or bleeding disorders.
8. 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.
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