Benign and Malignant Hematologic DiseasesNCT03535220
The American Society of Hematology (ASH) Research Registry: A Multicenter Research Registry of Patients With Hematologic Disease
An observational study of Benign and Malignant Hematologic Diseases, run by American Society of Hematology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Benign and Malignant Hematologic Diseases
- What is being tested?
- Protease Inhibitors
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and Adult population
Who may be able to join
- 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.
Who cannot join
- Adults that are unable to consent.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
American Society of Hematology
Washington D.C., District of Columbia, 20036
About this study
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.
Read the 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.
- Being tested
- Protease Inhibitors
- Keywords
- Multiple Myeloma, Sickle Cell Disease
- Medical subject headings
- Multiple Myeloma, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protease InhibitorsCombination product
Also called Monoclonal Antibodies Proteasome inhibitors,
Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents
| Study group | Role | What they receive |
|---|---|---|
| Observational/ Interventional | Hematologic Disease Receives: Combination Product: Protease Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 Years
Secondary outcomes (1)
Patient reported outcomes (health-related QoL )
Health-related QoL
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start10 May 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign and Malignant Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society of Hematology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Thompson, MD,MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535220
- Sponsor's protocol ID
- 1185686
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The American Society of Hematology (ASH) Research Registry: A Multicenter Research Registry of Patients With Hematologic Disease
- ClinicalTrials.gov ID
- NCT03535220
- Acronym / sponsor ID
- 1185686
- Keywords
- Multiple Myeloma, Sickle Cell Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- American Society of HematologyUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational/ Interventional | – | Combination Product: Protease InhibitorsHematologic Disease |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and Adult population
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Adults that are unable to consent.
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protease InhibitorsAlso: Monoclonal Antibodies Proteasome inhibitors,Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents | Combination product | Observational/ Interventional |
Primary outcome
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.
1 secondary outcome
Patient reported outcomes (health-related QoL )
Time frame: Up to 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Benign and Malignant Hematologic Diseases
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InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Thompson, MD,MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign and Malignant Hematologic Diseases, run by American Society of Hematology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (time frame: Up to 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.