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Evaluation of the Association of Polymorphisms in the Innate Immune System With the Risk for Cryptococcus Neoformans Infection in Patients Not Infected With HIV and Complications Associated With Cryptococcus Neoformans Infection

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ClinicalTrials.gov Identifier: NCT00001701
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief Summary:
Innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. We hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with Cryptococcus neoformans. To test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb, Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of C neoformans infection. With this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive C neoformans infection.

Condition or disease
Cryptococcosis

Detailed Description:
Innate immunity plays an important role for fungal recognition and initiation of fungicidal activity. We hypothesize that subtle differences in different molecules of innate immunity may contribute to either the predisposition or clinical course of infection with Cryptococcus neoformans. To test this hypothesis, we propose to analyze the allelic frequencies of 15 different genes (mannose binding lectin, Fc-gamma receptor IIa and IIb, Fc-gamma receptors IIIa and IIIb, myeloperoxidase, tumor necrosis factor-alpha and -beta, interleukin 1A and 1B, interleukin-1 receptor antagonist, interleukin-10, NRAMP-1, chitotriosidase, and chemokine receptor 5) and their intragenic polymorphic forms and to compare this data to the incidence and severity of C neoformans infection. With this study we hope to identify a group of molecules of innate immunity which influence the risk and severity of invasive C neoformans infection.

Study Design
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Study Type : Observational
Enrollment : 300 participants
Official Title: Evaluation of the Association of Polymorphisms in the Innate Immune System With the Risk for Cryptococcus Neoformans Infection in Patients Not Infected With HIV and Complications Associated With Cryptococcus Neoformans Infection
Study Start Date : July 29, 1998
Actual Primary Completion Date : June 21, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients diagnosed with Cryptococcus neoformans infection will be identified from a data base overseen by Dr. Peter Pappas.

Only patients diagnosed and treated in the United States and Canada will be included in this analysis.

Only patients who are not coinfected with HIV will be included in the study.

Patient samples will be collected and clinical data will be evaluated only after signed informed consent has been obtained.

Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001701


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States
Sponsors and Collaborators
National Cancer Institute (NCI)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

ClinicalTrials.gov Identifier: NCT00001701     History of Changes
Other Study ID Numbers: 980137
98-C-0137
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: October 6, 2009

Keywords provided by National Institutes of Health Clinical Center (CC):
Risk Factor
Genetic
Variant Alleles
Cancer
Transplantation

Additional relevant MeSH terms:
Infection
Cryptococcosis
Mycoses