NCT00001701

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2007

Completed
Last Updated

July 2, 2017

Status Verified

October 6, 2009

Enrollment Period

8.9 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Cryptococcosis

Keywords

Risk FactorGeneticVariant AllelesCancerTransplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Birmingham, Alabama, United States

Location

Related Publications (3)

  • 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.

    PMID: 9486992BACKGROUND

  • 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.

    PMID: 7945503BACKGROUND

  • 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.

    PMID: 7592832BACKGROUND

MeSH Terms

Conditions

CryptococcosisNeoplasms

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 29, 1998

Primary Completion

June 21, 2007

Last Updated

July 2, 2017

Record last verified: 2009-10-06

Locations

US(1)