- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03535220
The American Society of Hematology (ASH) Research Registry: A Multicenter Research Registry of Patients With Hematologic Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20036
- American Society of Hematology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Observational/ Interventional
Hematologic Disease
|
Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimal Residual Disease
Time Frame: Up to 5 Years
|
Cancer cells from the bone marrow) that remain in the patient during treatment, or after treatment when the patient is in remission e.g. 3 months, 6 months, one year, or end of current treatment.
|
Up to 5 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported outcomes (health-related QoL )
Time Frame: Up to 5 Years
|
Health-related QoL
|
Up to 5 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexis Thompson, MD,MPH, Ann & Robert H Lurie Children's Hospital of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1185686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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