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:

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:

Risk Factors

Epidemiology

BMT/SCT

Recruitment Keyword(s):

Fungal Infection

Bone Marrow Stem Cell Transplant

Organ Transplant

Epidemiology

Condition(s):

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

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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