Human Blood Cell DisordersNCT00902447
Human Blood Cell Disorders Tissue Bank
An observational study of Human Blood Cell Disorders and Lymphoid, Myeloid and Erythroid Proliferative Disease, run by Northwell Health at 1 site in United States.
Trial summary
The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of tissue containing populations of human blood cells from patients with various types of lymphoid, myeloid, and erythroid proliferative diseases as well as other associated conditions. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Blood Cell Disorders, Lymphoid, Myeloid and Erythroid Proliferative Disease
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2035
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Participants or participant's Legally Authorized Representatives (LAR) must be able to understand and render voluntary, written informed consent.
- Patients must be able to contribute the required amount of blood and/or tissue without compromising their well-being or care.
- Participants must be willing to be contacted again for consideration of additional studies in the future, such as a blood draw or another action (e.g., bone marrow aspiration and/or biopsy) that would be done as part of their standard of care.
Who cannot join
- Patients who are known to be anemic, with hemoglobin <8.0g/dl.
- Patients who are known to be infected with HIV.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yasmine Kieso, MSCR contact
United States1 site, 1 recruiting
- Recruiting
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
Yasmine Kieso, MSCR, ykieso@northwell.edu
Nicholas Chiorazzi, M.D.
About this study
The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of tissue containing populations of human blood cells from patients with various types of lymphoid, myeloid, and erythroid proliferative diseases as well as other associated conditions. The tissue bank will continue to be an invaluable asset for understanding of the biology of multiple blood cell disorders involving several cell types as well as the physiology of normal cellular counterparts affected in these disorders. Internal and external investigators will be able to utilize this tissue to test hypotheses relating to the immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as normal cells from normal unaffected family members or normal aged matched subjects to provide better comparisons.
- Keywords
- Human Blood Cell Disorders, lymphoid, myeloid and erythroid proliferative disease
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 |
|---|---|---|
| Human Blood Cell Disorders | Human Blood Cell Disorders Tissue Bank |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulate tissue from patients with various blood disorders, including but not restricted to lymphoproliferative, myeloproliferative, and erythroproliferative conditions.
Measured: Indefinite
Secondary outcomes (1)
Develop a database of at least 10,000 subjects who have donated samples for research as well as DNA banking, and who are willing to be contacted again for consideration of additional studies in the future.
Measured: Indefinite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2030 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Blood Cell DisordersStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Chiorazzi, M.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902447
- Sponsor's protocol ID
- 08-202
- Status last verified
- Mar 2024
- First submitted
- 13 May 2009
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Blood Cell Disorders Tissue Bank
- ClinicalTrials.gov ID
- NCT00902447
- Acronym / sponsor ID
- 08-202
- Keywords
- Human Blood Cell Disorders, lymphoid, myeloid and erythroid proliferative disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 15 May 2009 (estimated)
- 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.
The Human Blood Cell Disorder Tissue Bank will provide a convenient, comprehensive source of tissue containing populations of human blood cells from patients with various types of lymphoid, myeloid, and erythroid proliferative diseases as well as other associated conditions. The tissue bank will continue to be an invaluable asset for understanding of the biology of multiple blood cell disorders involving several cell types as well as the physiology of normal cellular counterparts affected in these disorders. Internal and external investigators will be able to utilize this tissue to test hypotheses relating to the immunologic, virologic, genetic, and molecular properties of these abnormal cells as well as normal cells from normal unaffected family members or normal aged matched subjects to provide better comparisons.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Blood Cell Disorders | – | –Human Blood Cell Disorders Tissue Bank |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Participants or participant's Legally Authorized Representatives (LAR) must be able to understand and render voluntary, written informed consent.
- Patients must be able to contribute the required amount of blood and/or tissue without compromising their well-being or care.
- Participants must be willing to be contacted again for consideration of additional studies in the future, such as a blood draw or another action (e.g., bone marrow aspiration and/or biopsy) that would be done as part of their standard of care.
Key exclusion criteria (2 listed)
- Patients who are known to be anemic, with hemoglobin <8.0g/dl.
- Patients who are known to be infected with HIV.
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
Accumulate tissue from patients with various blood disorders, including but not restricted to lymphoproliferative, myeloproliferative, and erythroproliferative conditions.
Time frame: Indefinite
1 secondary outcome
Develop a database of at least 10,000 subjects who have donated samples for research as well as DNA banking, and who are willing to be contacted again for consideration of additional studies in the future.
Time frame: Indefinite
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 27 Mar 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.
Yasmine Kieso, MSCR contact
Nicholas Chiorazzi, M.D. principal investigator
Northwell Health
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 Human Blood Cell Disorders and Lymphoid, Myeloid and Erythroid Proliferative Disease, run by Northwell Health 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 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 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?
Contact Yasmine Kieso, MSCR (ykieso@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulate tissue from patients with various blood disorders, including but not restricted to lymphoproliferative, myeloproliferative, and erythroproliferative conditions. (time frame: Indefinite). 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 27 Mar 2024.