RECRUITING

Fungal Infection Susceptibility

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Conditions

Cryptococcal InfectionCryptococcal PneumoniaPulmonary CryptococcosisCryptococcal MeningitisCryptococcosisNatural HistoryCryptococcusCryptococcus NeoformansCryptococcus gattii

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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

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. ...

Official Title

Cryptococcosis in Previously Healthy Adults

Quick Facts

Study Start:1993-04-01
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00001352

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 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have cryptococcosis as determined by information collected from their medical records, telephone interviews, or from a referring physician:
  2. * histopathology showing cryptococci; or
  3. * culture of C. neoformans or C. gattii
  4. * a positive cryptococcal antigen in the serum and/or CSF, together with CSF cell count and chemistry consistent with cryptococcal meningitis.
  5. 2. Be over the age of 18 years old.
  6. 3. Have a primary physician outside of the NIH.
  7. 4. Agree to undergo genetic testing that will include WES and high density SNP arrays as appropriate for possible WES linkage studies.
  8. 5. Allow samples to be stored for future research.
  9. 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.
  10. 1. Be a genetic relative of a patient enrolled in this study
  11. 2. Be over the age of 18 years old
  12. 3. Agree to undergo genetic testing that may include WES and high density SNP analysis
  13. 4. Allow samples to be stored for future research
  14. 1. Be between the ages of 18 and 70 years old
  15. 2. Allow samples to be stored for future research
  1. 1. The presence of certain types of acquired abnormalities of immunity due to:
  2. * HIV
  3. * Cancer chemotherapeutic agent(s)
  4. * 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
  5. * Monoclonal antibody therapy directed against a patient s immune system
  6. 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.
  7. 1. HIV or viral hepatitis (B or C).
  8. 2. History of recurrent or severe infections.
  9. 3. History of intravenous drug use.
  10. 4. History of engaging in high-risk activities for exposure to HIV.
  11. 5. Receiving chemotherapeutic agent(s), immunosuppressants or have underlying malignancy.
  12. 6. Pregnancy.
  13. 7. Have history of heart, lung, kidney disease, or bleeding disorders.
  14. 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.

Contacts and Locations

Study Contact

Peter R Williamson, M.D.
CONTACT
(301) 443-8339
williamsonpr@mail.nih.gov

Principal Investigator

Peter R Williamson, 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)

  • Peter R Williamson, 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 Date1993-04-01
Study Completion DateN/A

Study Record Updates

Study Start Date1993-04-01
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Natural History
  • Cryptococcus
  • Cryptococcus Neoformans
  • Cryptococcus gattii

Additional Relevant MeSH Terms

  • Cryptococcal Infection
  • Cryptococcal Pneumonia
  • Pulmonary Cryptococcosis
  • Cryptococcal Meningitis
  • Cryptococcosis