The American Society of Hematology (ASH) Research Registry: A Multicenter Research Registry of Patients With Hematologic Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 1 - 65 |
| Updated: | 5/26/2018 |
| Start Date: | May 10, 2018 |
| End Date: | January 31, 2025 |
This is a multicenter, retrospective and prospective, long-term registry of patients with
benign or malignant hematologic diseases, whether or not these patients were or were not
treated with disease-specific treatments. Information will be collected on patient
demographics, disease characteristics, genomic and molecular data, laboratory data,
pathology, radiographic reports, clinical status, quality of life, medications, and dosing
information. Where appropriate, these data structures may be based on a combination of Fast
Healthcare Interoperability Resources (FHIR) , Consolidated-Clinical Data Architecture
(C-CDA) and/or client-specific structure definitions.
benign or malignant hematologic diseases, whether or not these patients were or were not
treated with disease-specific treatments. Information will be collected on patient
demographics, disease characteristics, genomic and molecular data, laboratory data,
pathology, radiographic reports, clinical status, quality of life, medications, and dosing
information. Where appropriate, these data structures may be based on a combination of Fast
Healthcare Interoperability Resources (FHIR) , Consolidated-Clinical Data Architecture
(C-CDA) and/or client-specific structure definitions.
The primary goal of the ASH Registry is to further the scientific knowledge base for the
diagnosis, understanding, and management of benign and malignant hematologic conditions by
assembling data collected in usual care and clinical trials. Secondary goals are to
characterize and study practice patterns for benign and malignant hematologic conditions in
usual clinical practice, and to aggregate patient-reported data to further understand and
improve the patient experiences of those affected by these conditions. These objectives will
be fulfilled by amassing previously collected data within institutions and networks, and by
building consortia of institutions and networks to support prospective data collection
efforts.
As a research-focused effort, another objective of the ASH Registry is to create a learning
community of hematologic researchers and clinicians by inviting collaborative analyses and
publications of the data that are collected within it. These analyses may be valuable to
basic and translational researchers developing new lines of scientific inquiry; clinical
researchers studying the safety and efficacy of hematologic therapies in current practice;
industry participants developing new therapies or new indications for previously developed
treatments; regulators who are interested in new endpoints and other insights to facilitate
the evaluation of novel approaches; and patients who are looking to understand how
hematologic diseases and treatments for these diseases will affect their lives. As these
different stakeholder groups come together to develop and disseminate these analyses, the ASH
Registry will further expand to accommodate additional data collection to address yet
unanswered questions that follow.
diagnosis, understanding, and management of benign and malignant hematologic conditions by
assembling data collected in usual care and clinical trials. Secondary goals are to
characterize and study practice patterns for benign and malignant hematologic conditions in
usual clinical practice, and to aggregate patient-reported data to further understand and
improve the patient experiences of those affected by these conditions. These objectives will
be fulfilled by amassing previously collected data within institutions and networks, and by
building consortia of institutions and networks to support prospective data collection
efforts.
As a research-focused effort, another objective of the ASH Registry is to create a learning
community of hematologic researchers and clinicians by inviting collaborative analyses and
publications of the data that are collected within it. These analyses may be valuable to
basic and translational researchers developing new lines of scientific inquiry; clinical
researchers studying the safety and efficacy of hematologic therapies in current practice;
industry participants developing new therapies or new indications for previously developed
treatments; regulators who are interested in new endpoints and other insights to facilitate
the evaluation of novel approaches; and patients who are looking to understand how
hematologic diseases and treatments for these diseases will affect their lives. As these
different stakeholder groups come together to develop and disseminate these analyses, the ASH
Registry will further expand to accommodate additional data collection to address yet
unanswered questions that follow.
Inclusion Criteria:
- Patients (>18 years of age) must have diagnostically- or investigator-confirmed benign
or malignant hematologic disease.
- For prospective data collection efforts within the ASH Registry that require informed
consent, children (<18 years of age) with hematologic disease whose parent/legal
guardian consents on their behalf may be included.
Exclusion Criteria:
- Adults that are unable to consent.
- Prisoners
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