Bone Marrow DiseasesNCT00001627
Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes
An observational study of Bone Marrow Diseases and Healthy Volunteers, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study is designed to provide bone marrow and/or blood cells for other research studies. Patients participating in this study will be asked to provide small amounts of medical information and undergo a limited physical examination designed to detect the presence of any obvious blood disease. Read more about this study
- Who is it for?
- Ages 2 to 110 years
- Conditions the study is for
- Bone Marrow Diseases, Healthy Volunteers
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 1997to 22 Dec 2010
- 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 2 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Normal Volunteers and patients
Who may be able to join
- Healthy volunteers age greater than or equal to 18 years.
- Subjects with hematologic disease age greater than or equal to 2 (for subjects less than 18, blood and bone marrow specimens will be obtained concurrently with clinically indicated sampling).
Who cannot join
- History of a significant bleeding disorder.
- Abnormal host-defense mechanisms.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
This study is designed to provide bone marrow and/or blood cells for other research studies. Patients participating in this study will be asked to provide small amounts of medical information and undergo a limited physical examination designed to detect the presence of any obvious blood disease. A blood and bone marrow sample will be obtained to verify that the patient has normal blood cell production.
Researchers plan to obtain bone marrow samples to be used in laboratory studies directed toward understanding the formation of blood cells. Bone marrow samples will be taken from the hip bone of patients and healthy volunteers.
These samples are valuable to many research studies within the Hematology Branch of the National Heart, Lung, and Blood Institute, including studies of normal and abnormal production of blood cells, the viral causes of blood diseases, and the role of the immune system in bone marrow failure and related conditions....
Read the detailed description
This protocol defines in general terms the purposes for which blood and bone marrow specimens will be collected by members of the Hematology Branch and the conditions under which the sampling will be performed. Samples of blood and bone marrow from healthy volunteers and from patients are indispensable for many research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, and the role of the immune system in marrow failure and related conditions.
- Conditions
- Bone Marrow Diseases, Healthy Volunteers
- Keywords
- Bone Marrow, Hematopoiesis, DNA, RNA, Viruses
- Medical subject headings
- Bone Marrow Diseases, Virus Diseases
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 |
|---|---|---|
| Group 1 | Normal Volunteers and patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide a readily available supply of samples for blood and bone marrow for in vitro studies in the Hematology Branch laboratories
The collection of adequate cells for laboratory research.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start8 Jul 1997
- Primary completion22 Dec 2010
- Study completion22 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neal S Young, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001627
- Sponsor's protocol ID
- 970130
- Other IDs
- 97-H-0130
- Status last verified
- Oct 2020
- First submitted
- 3 Nov 1999
- Last updated
- 8 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood and Bone Marrow From Healthy Volunteers and Patients for Research Purposes
- ClinicalTrials.gov ID
- NCT00001627
- Acronym / sponsor ID
- 970130
- Conditions
- Bone Marrow Diseases, Healthy Volunteers
- Keywords
- Bone Marrow, Hematopoiesis, DNA, RNA, Viruses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 8 Jul 1997 (actual)
- Primary completion
- 22 Dec 2010 (actual)
- Study completion
- 22 Dec 2010 (actual)
- First posted
- 4 Nov 1999 (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.
This study is designed to provide bone marrow and/or blood cells for other research studies. Patients participating in this study will be asked to provide small amounts of medical information and undergo a limited physical examination designed to detect the presence of any obvious blood disease. A blood and bone marrow sample will be obtained to verify that the patient has normal blood cell production.
Researchers plan to obtain bone marrow samples to be used in laboratory studies directed toward understanding the formation of blood cells. Bone marrow samples will be taken from the hip bone of patients and healthy volunteers.
These samples are valuable to many research studies within the Hematology Branch of the National Heart, Lung, and Blood Institute, including studies of normal and abnormal production of blood cells, the viral causes of blood diseases, and the role of the immune system in bone marrow failure and related conditions....
Detailed description
This protocol defines in general terms the purposes for which blood and bone marrow specimens will be collected by members of the Hematology Branch and the conditions under which the sampling will be performed. Samples of blood and bone marrow from healthy volunteers and from patients are indispensable for many research projects, including studies of normal and abnormal hematopoiesis, the viral etiology of blood diseases, and the role of the immune system in marrow failure and related conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Normal Volunteers and patients. |
Who may qualify
- Ages
- 2 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Normal Volunteers and patients
Key inclusion criteria (2 listed)
- Healthy volunteers age greater than or equal to 18 years.
- Subjects with hematologic disease age greater than or equal to 2 (for subjects less than 18, blood and bone marrow specimens will be obtained concurrently with clinically indicated sampling).
Key exclusion criteria (2 listed)
- History of a significant bleeding disorder.
- Abnormal host-defense mechanisms.
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
To provide a readily available supply of samples for blood and bone marrow for in vitro studies in the Hematology Branch laboratories
Time frame: Ongoing
The collection of adequate cells for laboratory research.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Neal S Young, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Bone Marrow Diseases and Healthy Volunteers, run by National Heart, Lung, and Blood Institute (NHLBI) 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To provide a readily available supply of samples for blood and bone marrow for in vitro studies in the Hematology Branch laboratories (time frame: Ongoing). 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 8 Oct 2020.