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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02560883
Registration number
NCT02560883
Ethics application status
Date submitted
20/08/2015
Date registered
25/09/2015
Date last updated
16/04/2025
Titles & IDs
Public title
Hairy Cell Leukemia Patient Data Registry
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Scientific title
Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia
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Secondary ID [1]
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OSU-12194
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Universal Trial Number (UTN)
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Trial acronym
HCL-PDR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia, Other
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Surveillance
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Assessment method [1]
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Establish a database of Hairy Cell Leukemia patients diagnosed or living in US to track Hairy Cell Leukemia disease course, patient reported outcomes, morbidity, and patient survival.
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Timepoint [1]
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up to 25 years
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Secondary outcome [1]
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Research
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Assessment method [1]
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facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. Assess the number and type of infections recorded in patients following diagnosis and before therapy versus the infectious complications following administration of therapy for the disease. Identify and characterize patients at each participating institution with autoimmune complications associated with their diagnosis (e.g., polyarticular arthritis; immune cytopenias; vasculitis), and describe the response to immunosuppressive therapy. Collect data regarding treatment for hairy cell leukemia and its impact on the autoimmune complications of the disease.
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Timepoint [1]
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up to 25 years
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Eligibility
Key inclusion criteria
Inclusion:
* Patients with classic hairy cell leukemia
* Patients with the variant of hairy cell leukemia.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion:
* Children are excluded from the study, since Hairy Cell Leukemia wasn't described in children.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2030
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Center - Melbourne
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Recruitment postcode(s) [1]
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VIC 3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Minnesota
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Ohio
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Country [5]
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Canada
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State/province [5]
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Manitoba
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ohio State University Comprehensive Cancer Center
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Hairy Cell Leukemia Foundation
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and/or mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 1,000 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.
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Trial website
https://clinicaltrials.gov/study/NCT02560883
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Michael Grever, MD
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Address
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The Ohio State University Comprehensive Cancer Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Hairy Cell Leukemia Research Data Registry
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Address
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Country
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Phone
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614-685-4296
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02560883
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