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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT03014934 |
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Date of registration:
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06/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Pre-existing Invasive Aspergillosis on Allogeneic Stem Cell Transplantation
IPAT |
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Scientific title:
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Impact of Pre-existing Invasive Aspergillosis on Allogeneic Hematopoietic Stem Cell Transplantation for Treatment of Acute Leukaemia and Myelodysplastic Syndrome |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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2100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03014934 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Italy
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Saudi Arabia
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Spain
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Switzerland
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Turkey
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Contacts
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Name:
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Jan Styczynski |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Collegium Medicum UMK |
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Name:
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Jennifer Hoek, MD |
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Address:
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Telephone:
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+31715265668 |
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Email:
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j.d.c.hoek@lumc.nl |
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Affiliation:
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Name:
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Olaf Penack, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charite University, Berlin, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First allo-HSCT
- Acute leukaemia or MDS
- Received stem cell grafts
Exclusion Criteria:
- History, in the 6 months preceding HSCT, or documented presence of Invasive candida or
mould infections other than IA (Mucor, Fusariosis).
- (Previous history Candida infection, both superficial or systemic, is not an exclusion
criteria if the patient has completely recovered from it at HSCT).
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Invasive Aspergillosis
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Primary Outcome(s)
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Non-relapse mortality
[Time Frame: 1 year]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 1 year]
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Incidence and severity of Graft versus Host Disease
[Time Frame: 1 year]
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Incidence of relapse
[Time Frame: 1 year]
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Relapse free survival
[Time Frame: 1 year]
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Status of Invasive Aspergillosis
[Time Frame: 1 year]
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Secondary ID(s)
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EBMT-8414113
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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