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Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)

NCT ID: NCT01254318

Last Updated: 2016-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-11-30

Brief Summary

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This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.

Detailed Description

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Conditions

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Mycoses Leukemia

Keywords

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hematological malignancy fungal infection leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants at high risk for IFI

Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.

Standard Care

Intervention Type OTHER

Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.

Interventions

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Standard Care

Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* To be eligible for study inclusion, the participant must have:
* A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant

Exclusion Criteria

* The participant is not eligible for study inclusion if:
* Their IFI is not related to hematological malignancies.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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MK-5592-071

Identifier Type: OTHER

Identifier Source: secondary_id

P07501

Identifier Type: -

Identifier Source: org_study_id