Sickle Cell DiseaseNCT05775224
ASH Research Collaborative Data Hub
An observational study of Sickle Cell Disease and Multiple Myeloma, run by ASH Research Collaborative at 1 site in United States.
Trial summary
Benign and malignant hematologic diseases are relatively rare conditions within the spectrum of medical practice in any one site of care. Nonetheless, recent research in hematologic conditions from basic, translational, clinical and population perspectives offer the possibility of improving the way that these diseases… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease, Multiple Myeloma
- How many people
- 100,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2020to 29 Apr 2099
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There will be no discrimination or bias with respect to inclusion on the basis of sex, race, or religion.
To be included in the Data Hub, patients must have documented sickle cell disease and/or active multiple myeloma since 2015.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
ASH Research Collaborative
Washington D.C., District of Columbia, 20036
About this study
Official title: ASH Research Collaborative Data Hub Protocol: A Multi-Center Data Hub of Individuals Living With Hematologic Disease
Benign and malignant hematologic diseases are relatively rare conditions within the spectrum of medical practice in any one site of care. Nonetheless, recent research in hematologic conditions from basic, translational, clinical and population perspectives offer the possibility of improving the way that these diseases are treated, and the outcomes experienced by patients. A repository that aggregates and validates this data across institutions and other practice settings is needed in order to identify variation in care, new findings, and further research.
Read the detailed description
The ASH Research Collaborative (ASH RC) is a non-profit organization established by the American Society of Hematology (ASH) in 2018 that aims to improve the lives of those affected by blood diseases by fostering collaborative partnerships to accelerate progress in hematology. The foundation of the ASH RC is its Data Hub, a technology platform that facilitates the exchange of information by aggregating in one place, and making available for inquiry, research-grade data on hematologic diseases. In 2019, ASH RC launched its first research initiative, the Sickle Cell Disease (SCD) Clinical Trials Network (CTN), with the goal of optimizing SCD clinical research operations. As part of its core functions, the SCD-CTN leverages the Data Hub to collect key information and identify gaps that will help advance SCD research and treatment.
The primary goal of the Data Hub is to further the scientific knowledge base for the diagnosis, understanding, and management of benign and malignant hematologic conditions by assembling data collected in routine clinical care and closed clinical trials. Secondary goals are to characterize and study practice patterns for benign and malignant hematologic conditions in clinical practice, and to aggregate patient-reported data to further understand and improve the patient experience. These objectives will be fulfilled by amassing data from patients' electronic medical records and other data sources within institutions and networks to support prospective data collection efforts, such as those that include patient reported outcomes.
- Conditions
- Sickle Cell Disease, Multiple Myeloma
- Keywords
- SCD, Sickle Cell, Myeloma
- Medical subject headings
- Anemia, Sickle Cell, Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease | Not described | |
| Multiple Myeloma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Aims of the Data Hub include collecting clinical data to gain further insights about diagnosis, treatment, prognosis, and risk factors of hematologic disorders.
Measured: 50 year recruitment period (there will be continuous subgroup analyses through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start29 Apr 2020
- Primary completion29 Apr 2099 (estimated)
- Study completion29 Apr 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- ASH Research Collaborative
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775224
- Sponsor's protocol ID
- 20181051
- Status last verified
- Jun 2024
- First submitted
- 13 Jan 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASH Research Collaborative Data Hub Protocol: A Multi-Center Data Hub of Individuals Living With Hematologic Disease
- ClinicalTrials.gov ID
- NCT05775224
- Acronym / sponsor ID
- 20181051
- Conditions
- Sickle Cell Disease, Multiple Myeloma
- Keywords
- SCD, Sickle Cell, Myeloma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- ASH Research CollaborativeUniversity, hospital or other
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 29 Apr 2099 (estimated)
- Study completion
- 29 Apr 2099 (estimated)
- First posted
- 20 Mar 2023 (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.
Benign and malignant hematologic diseases are relatively rare conditions within the spectrum of medical practice in any one site of care. Nonetheless, recent research in hematologic conditions from basic, translational, clinical and population perspectives offer the possibility of improving the way that these diseases are treated, and the outcomes experienced by patients. A repository that aggregates and validates this data across institutions and other practice settings is needed in order to identify variation in care, new findings, and further research.
Detailed description
The ASH Research Collaborative (ASH RC) is a non-profit organization established by the American Society of Hematology (ASH) in 2018 that aims to improve the lives of those affected by blood diseases by fostering collaborative partnerships to accelerate progress in hematology. The foundation of the ASH RC is its Data Hub, a technology platform that facilitates the exchange of information by aggregating in one place, and making available for inquiry, research-grade data on hematologic diseases. In 2019, ASH RC launched its first research initiative, the Sickle Cell Disease (SCD) Clinical Trials Network (CTN), with the goal of optimizing SCD clinical research operations. As part of its core functions, the SCD-CTN leverages the Data Hub to collect key information and identify gaps that will help advance SCD research and treatment.
The primary goal of the Data Hub is to further the scientific knowledge base for the diagnosis, understanding, and management of benign and malignant hematologic conditions by assembling data collected in routine clinical care and closed clinical trials. Secondary goals are to characterize and study practice patterns for benign and malignant hematologic conditions in clinical practice, and to aggregate patient-reported data to further understand and improve the patient experience. These objectives will be fulfilled by amassing data from patients' electronic medical records and other data sources within institutions and networks to support prospective data collection efforts, such as those that include patient reported outcomes.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease | – | – |
| Multiple Myeloma | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There will be no discrimination or bias with respect to inclusion on the basis of sex, race, or religion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data Collection
Time frame: 50 year recruitment period (there will be continuous subgroup analyses through study completion)
Aims of the Data Hub include collecting clinical data to gain further insights about diagnosis, treatment, prognosis, and risk factors of hematologic disorders.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sickle Cell Disease and Multiple Myeloma, run by ASH Research Collaborative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Data Collection (time frame: 50 year recruitment period (there will be continuous subgroup analyses through study completion)). 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 17 Jun 2024; AzTrials last refreshed its copy on 3 Nov 2026.