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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

Primary Purpose

Cryptococcosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cryptococcosis focused on measuring Risk Factor, Genetic, Variant Alleles, Cancer, Transplantation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001701
Brief 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
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 Type
Observational

2. Study Status

Record Verification Date
October 6, 2009
Overall Recruitment Status
Completed
Study Start Date
July 29, 1998 (undefined)
Primary Completion Date
June 21, 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cryptococcosis
Keywords
Risk Factor, Genetic, Variant Alleles, Cancer, Transplantation

7. Study Design

Enrollment
300 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9486992
Citation
Bellamy R, Ruwende C, Corrah T, McAdam KP, Whittle HC, Hill AV. Variations in the NRAMP1 gene and susceptibility to tuberculosis in West Africans. N Engl J Med. 1998 Mar 5;338(10):640-4. doi: 10.1056/NEJM199803053381002.
Results Reference
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PubMed Identifier
7945503
Citation
Blakemore AI, Tarlow JK, Cork MJ, Gordon C, Emery P, Duff GW. Interleukin-1 receptor antagonist gene polymorphism as a disease severity factor in systemic lupus erythematosus. Arthritis Rheum. 1994 Sep;37(9):1380-5. doi: 10.1002/art.1780370917.
Results Reference
background
PubMed Identifier
7592832
Citation
Boot RG, Renkema GH, Strijland A, van Zonneveld AJ, Aerts JM. Cloning of a cDNA encoding chitotriosidase, a human chitinase produced by macrophages. J Biol Chem. 1995 Nov 3;270(44):26252-6. doi: 10.1074/jbc.270.44.26252.
Results Reference
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Learn more about this trial

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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