Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03535220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2018-05-24
First Post:
2018-05-11
Brief Title:
The American Society of Hematology ASH Research Registry A Multicenter Research Registry of Patients With Hematologic Disease
Sponsor:
American Society of Hematology
Organization:
American Society of Hematology
Study Overview
Official Title:
The American Society of Hematology ASH Research Registry A Multicenter Research Registry of Patients With Hematologic Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor client-specific structure definitions
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None