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

NCT03535220 | Unknown FDA Drug FDA Device

• 1 other identifier: 1185686
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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) and/or client-specific structure definitions.

Conditions

Benign and Malignant Hematologic Diseases

Keywords

Multiple Myeloma; Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Minimal Residual Disease

  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 Outcomes (1)

• Patient reported outcomes (health-related QoL )

  Up to 5 Years

Study Arms (1)

Observational/ Interventional

Hematologic Disease

Combination Product: Protease Inhibitors

Interventions

Protease Inhibitors COMBINATION_PRODUCT

Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents

Also known as: Monoclonal Antibodies Proteasome inhibitors,

Observational/ Interventional

Eligibility Criteria

• Age: 1 Year - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and Adult population

You may qualify if:

• 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.

You may not qualify if:

• Adults that are unable to consent.
• Prisoners

Sponsors & Collaborators

• American Society of Hematology: lead

Study Sites (1)

American Society of Hematology

Washington D.C., District of Columbia, 20036, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Anemia, Sickle Cell

Interventions

Protease Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Alexis Thompson, MD,MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 24, 2018
• Study Start: May 10, 2018
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2025
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

US (1)