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

May 22, 2018 updated by: American Society of Hematology
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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20036
        • American Society of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric and Adult 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Monoclonal Antibodies Proteasome inhibitors,

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alexis Thompson, MD,MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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