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Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients - Article


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Nail fungus

Nail fungal infection


Clinical Trial: Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients

This study is currently recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients.

Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study.

The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections.

The study will be conducted in three phases as follows:

- Phase 1 - A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections.

- Phase 2 - A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion.

- Phase 3 - A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase.

Patient care will be provided through the patient's primary protocol and standard of care.

Condition
Fungus Disease

MedlinePlus related topics:  Fungal Infections

Study Type: Observational
Study Design: Natural History

Official Title: Surveillance of Invasive Fungal Infections in Bone Marrow/Stem Cell and Solid Organ Transplantation Recipients: A Prospective, Multicenter Study

Further Study Details: 

Expected Total Enrollment:  250

Study start: April 9, 2001

The objective of this study is to conduct national surveillance for invasive fungal infections in recipients of bone marrow, stem cell transplantation, or solid organ transplantations. This study will be conducted over a six year period at approximately 23 collaborating transplant centers. The study will commence January 1, 2001, through February 28, 2006. Through the annual accrual of over 9,000 patients, it is estimated that at least 5-8 percent of these patients (~650) will be accrued annually with documented or suspected invasive fungal infections. This will provide the necessary epidemiologic information to develop strategies for prevention and early intervention for invasive fungal infections in this population.

Eligibility

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA
Any patient receiving a bone marrow transplantation, peripheral stem cell transplantation, or solid organ transplantation.
EXCLUSION CRITERIA:
Any patient not receiving a bone marrow transplantation , peripheral stem cell transplantation, or solid organ transplantation.

Location and Contact Information


Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Study ID Numbers:  010144; 01-C-0144
Record last reviewed:  March 1, 2005
Last Updated:  February 24, 2005
Record first received:  November 14, 2001
ClinicalTrials.gov Identifier:  NCT00026767
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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September 5, 2008



Page Updated: September 30, 2005
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