Clinical Research in Hairy Cell Leukemia:Surveillance and Documentation of Clinical Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/16/2017 |
| Start Date: | January 2013 |
| End Date: | December 2025 |
| Contact: | Hairy Cell Leukemia Research Data Registry |
| Email: | HCLRegistry@osumc.edu |
| Phone: | 614-685-4296 |
Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia
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.
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.
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
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
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.
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