Protocol Number:
01-C-0144
- Title:
Surveillance of Invasive Fungal Infections in Bone Marrow/Stem Cell and Solid Organ Transplantation Recipients: A Prospective, Multicenter 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:
-
National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Active Accrual Of New Subjects
- 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.
EXCLUSION CRITERIA:
Any patient not receiving a bone marrow transplantation , peripheral stem cell transplantation, or solid organ transplantation.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Risk Factors
-
Epidemiology
-
BMT/SCT
- Recruitment Keywords:
-
Fungal Infection
-
Bone Marrow Stem Cell Transplant
-
Organ Transplant
-
Epidemiology
- Conditions:
-
Fungus Disease
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Contacts:
-
Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citations:
Not Provided
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Warren Grant Magnuson Clinical Center (CC) National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004
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