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Home > "S" Clinical Trials Conditions > Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients  Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients
Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients
For Condition: Fungus Disease
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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 four-year period at approximately 25 collaborating transplant centers. The study will commence January 1, 2001, through December 31, 2004. 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 250
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010144; 01-C-0144
Study Start Date: April 9, 2001
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026767
Other Fungus Disease Studies:
1. Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients
Related Studies:
Other Fungus Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Surveillance of Fungal Infections in Bone Marrow/Stem Cell and Organ Transplant Recipients
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