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Clinical Research in Hairy Cell Leukemia:Surveillance and Documentation of Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT02560883
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Hairy Cell Leukemia Foundation
Information provided by (Responsible Party):
Leslie Andritsos, Ohio State University Comprehensive Cancer Center

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 600 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.

Condition or disease
Leukemia, Other

Detailed Description:

This clinical registry is being established to collect de-identified information on this rare disease. The registry created by assimilation of de- identified coded patient data will centralize information that can be used to improve the management of the many complications of this disease and its treatment. This study is focused on collection of clinically and biologically meaningful endpoints across multiple institutions; as such, it is not focused on a specific set of hypotheses but will collect data that will facilitate such analyses. The investigators will collect information related to the symptoms and the clinical course of the disease, to the complications from the disease and its treatment, presence of minimal residual disease, frequency of relapse and subsequent management, data on novel molecular markers associated with the prognosis.

In conjunction with Dr. Philip Payne, Chairman of the Department of Bioinformatics at The Ohio State University, the investigators have created a system for safeguarding the confidentiality and the identity of all patients who agree to participate in this research registry. Each participating institution will be responsible for de-identification of the data, using software developed by The Ohio State University, Department of Biomedical Informatics, before it is used in the registry. Each institution will confidentially maintain a code for linking this information to an individual patient.

Each participating institution will have direct control over the data contained in the registry that is associated with their respective patient population, which will be housed locally (at the participating institution) and not replicated in a central location. As a result of these measures, should a patient wish to withdraw from the registry, the responsible institution will be able to immediately remove all records related to that patient from the registry


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia
Actual Study Start Date : January 2013
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia




Primary Outcome Measures :
  1. Surveillance [ Time Frame: up to 25 years ]
    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.


Secondary Outcome Measures :
  1. Research [ Time Frame: up to 25 years ]
    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.institutions. 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.


Other Outcome Measures:
  1. Contact [ Time Frame: up to 25 years ]
    Offer two-way communication with patients by providing information regarding Hairy Cell Leukemia, opportunities to participate in tissue banking, observational, and therapeutic clinical trials.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be a multi-institutional, international project that will collate clinical information from patients with Hairy Cell Leukemia from participating institutions in the Hairy Cell Leukemia Foundation.Initially, this study will be launched at three institutions (The Ohio State University in Columbus Ohio, M.D. Anderson Hospital in Houston Texas, and the Royal Marsden Hospital in London in the United Kingdom). Patients with HCL, who live in remote areas, without access to a HCLFCenter of Excellence, may voluntarily submit their name and contact information, through the Hairy Cell Leukemia Foundation website.
Criteria

Inclusion:

  • Patients with classic hairy cell leukemia
  • Patients with the variant of hairy cell leukemia.

Exclusion:

  • Children are excluded from the study, since Hairy Cell Leukemia wasn't described in children.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560883


Contacts
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Contact: Hairy Cell Leukemia Research Data Registry 614-685-4296 HCLRegistry@osumc.edu
Contact: Mirela Anghelina 614-685-4296

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Mirela Anghelina    614-685-4296    HCLRegistry@osumc.edu   
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Hairy Cell Leukemia Foundation
Investigators
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Principal Investigator: Leslie Andritsos, MD The Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Leslie Andritsos, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02560883     History of Changes
Other Study ID Numbers: OSU-12194
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Leslie Andritsos, Ohio State University Comprehensive Cancer Center:
Hairy Cell

Additional relevant MeSH terms:
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Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases