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Protocol Number:
01-C-0144
- Title:
Surveillance of Invasive Fungal Infections in Bone Marrow/Stem Cell and Solid Organ Transplantation Recipients and Other Immunocompromised Patients: A Prospective Study
- Number:
01-C-0144
- Summary:
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.
- Sponsoring Institute:
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National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
Yes
- Population Exclusion(s):
None
- Eligibility Criteria:
INCLUSION CRITERIA
Any patient receiving a bone marrow transplantation, peripheral stem cell transplantation, or solid organ transplantation, or any patient with an inherited immunodeficiency, aplastic anemia or oncologic diagnosis meeting EORTC/MSG criteria for an invasive infection.
EXCLUSION CRITERIA:
Any patient not receiving a bone marrow transplantation , peripheral stem cell transplantation, or solid organ transplantation, or not having an inherited immunodeficiency, aplastic anemia or oncologic diagnosis, and not meeting EORTC/MSG criteria for an invasive fungal infection.
- Special Instructions:
Currently Not Provided
- Keywords:
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Risk Factors
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Epidemiology
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BMT/SCT
- Recruitment Keyword(s):
-
Fungal Infection
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Bone Marrow Stem Cell Transplant
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Organ Transplant
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Epidemiology
- Condition(s):
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Fungus Disease
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Cancer Institute
- Contact(s):
-
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office Phone: 1-888-NCI-1937 Fax: Not Listed Electronic Address: ncicssc@mail.nih.gov
- Citation(s):
Not Provided
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Bethesda, Maryland 20892. Last update: 01/30/2009
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