The American Society of Hematology (ASH) Research Registry: A Multicenter Research Registry of Patients With Hematologic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-10

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign and Malignant Hematologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational/ Interventional

Hematologic Disease

Protease Inhibitors

Intervention Type COMBINATION_PRODUCT

Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents

Interventions

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Protease Inhibitors

Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Monoclonal Antibodies Proteasome inhibitors,

Eligibility Criteria

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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.