Non-atopicNCT00806364
Normal Blood, Bone Marrow and Buccal Mucosa Protocol
An observational study of Non-atopic and Atopic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells, mastocytosis, and allergic diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-atopic, Atopic, Healthy
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2009to 3 Nov 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Clinical
- PARTICIPANT INCLUSION CRITERIA:
Ability to sign informed consent.
Healthy male or female between 18-65 years of age.
Willing to have samples stored for future research.
PARTICIPANT EXCLUSION CRITERIA:
History of an immune deficiency, such as HIV infection or cancer.
History of chronic hepatitis B and/or C infection.
History of chronic anemia.
A known clotting disorder or taking medications that interfere with blood clotting, such as: aspirin, heparin, or Coumadin*
Current pregnancy.
Have taken an investigational drug in the last 6 months that may affect the normal process of blood cells.
Any condition that in the view of the principal investigator (PI) would make the subject unsuitable for enrollment in this study.
- Coumadin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If Coumadin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT and the PTT are within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7-day washout period will be required before bone marrow sampling.
BONE MARROW PROCEDURE EXCLUSION CRITERIA
hemoglobin less than the NIH Clinical Center Clinical Research Information System (CRIS) normal range.
Platelets less than 100,000/mm(3).
PT or PTT greater than the NIH Clinical Center CRIS normal range
Positive b-HCG.
EKG changes suggestive of cardiovascular disease.
unable or unwilling to have bone marrow biopsy performed without use of conscious sedation, and use of only local anesthetic during procedure
Any other lab value which may put the subject at risk during the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
This protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells, mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood, bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational nature of the studies in which their blood, bone marrow and buccal mucosa samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donations. Samples provided through this protocol will be used solely for in vitro research. Blood, bone marrow, and buccal mucosa samples will be assigned a unique product number and the study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.
Read the detailed description
This protocol is designed to provide blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors for use in in vitro studies such as studies of cells of the immune system, mastocytosis, and allergic diseases. Participants will donate samples using conventional techniques. The investigational nature of the studies in which samples will be used, as well as the risks and benefits of the donation process, will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donations. Samples provided through this protocol will be used solely for in vitro research. Samples will be assigned a unique product number, and the study investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research Protections, Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.
- Conditions
- Non-atopic, Atopic, Healthy, Normal, Allergy
- Keywords
- Skin, HV, Allergy, Healthy Volunteer, Non-atopic
- Medical subject headings
- Hypersensitivity
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 |
|---|---|---|
| 1 | Blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies.
To provide an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies.
Measured: 12/31/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study start26 Mar 2009
- Primary completion2 Jan 2021
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-atopicStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hirsh D Komarow, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806364
- Sponsor's protocol ID
- 090049
- Other IDs
- 09-I-0049
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2008
- Last updated
- 4 Jan 2023
- Results posted
- No
Publications
Vidal C, Gude F, Boquete O, Fernandez-Merino MC, Meijide LM, Rey J, Lojo S, Gonzalez-Quintela A. Evaluation of the phadiatop test in the diagnosis of allergic sensitization in a general adult population. J Investig Allergol Clin Immunol. 2005;15(2):124-30.
PubMed 16047713Hamilton RG, Adkinson NF Jr. 23. Clinical laboratory assessment of IgE-dependent hypersensitivity. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S687-701. doi: 10.1067/mai.2003.123.
PubMed 12592314Standards for blood banks and transfusion services. QRB Qual Rev Bull. 1977 Dec;3(12):17,22. No abstract available.
PubMed 414187
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Blood, Bone Marrow and Buccal Mucosa Protocol
- ClinicalTrials.gov ID
- NCT00806364
- Acronym / sponsor ID
- 090049
- Conditions
- Non-atopic, Atopic, Healthy, Normal, Allergy
- Keywords
- Skin, HV, Allergy, Healthy Volunteer, Non-atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Mar 2009 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 10 Dec 2008 (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 protocol is designed to provide blood, buccal mucosa and bone marrow aspirate samples from approximately 250, healthy volunteer donors for use in in vitro studies of mast cells, mastocytosis, and allergic diseases. Non-atopic donors will be recruited to donate blood, bone marrow, and/or buccal mucosa samples using conventional techniques. The investigational nature of the studies in which their blood, bone marrow and buccal mucosa samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donations. Samples provided through this protocol will be used solely for in vitro research. Blood, bone marrow, and buccal mucosa samples will be assigned a unique product number and the study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research (OHSR), Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.
Detailed description
This protocol is designed to provide blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors for use in in vitro studies such as studies of cells of the immune system, mastocytosis, and allergic diseases. Participants will donate samples using conventional techniques. The investigational nature of the studies in which samples will be used, as well as the risks and benefits of the donation process, will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donations. Samples provided through this protocol will be used solely for in vitro research. Samples will be assigned a unique product number, and the study investigators will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the blood collected in this study will be used is not the subject of this protocol and will be described in general terms only. The samples will be used in several Institutional Review Board (IRB)-approved Laboratory of Allergic Diseases (LAD) protocols. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, Office of Human Subjects Research Protections, Office for Human Research Protections (OHRP) and other applicable Federal regulatory standards.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Blood, skin, stool/rectal swabs, buccal mucosa and bone marrow aspirate samples from approximately 250 healthy volunteer donors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Clinical
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 an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies.
Time frame: 12/31/2030
To provide an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies.
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 4 Jan 2023.
- Background: PubMed 16047713Vidal C, Gude F, Boquete O, Fernandez-Merino MC, Meijide LM, Rey J, Lojo S, Gonzalez-Quintela A. Evaluation of the phadiatop test in the diagnosis of allergic sensitization in a general adult population. J Investig Allergol Clin Immunol. 2005;15(2):124-30.
- Background: PubMed 12592314Hamilton RG, Adkinson NF Jr. 23. Clinical laboratory assessment of IgE-dependent hypersensitivity. J Allergy Clin Immunol. 2003 Feb;111(2 Suppl):S687-701. doi: 10.1067/mai.2003.123.
- Background: PubMed 414187Standards for blood banks and transfusion services. QRB Qual Rev Bull. 1977 Dec;3(12):17,22. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Non-atopic
Active, not recruiting
Preventing Atopic Dermatitis and ALLergies in Children
Atopic Dermatitis, Food Allergy in Children
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.
Hirsh D Komarow, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Non-atopic and Atopic, run by National Institute of Allergy and Infectious Diseases (NIAID) 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?
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 4 Jan 2023. 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 an Institutional Review Board (IRB)-approved mechanism for the collection of peripheral blood, skin, bone marrow and/or buccal mucosa samples from healthy volunteer donors for use in in vitro studies. (time frame: 12/31/2030). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806364, which also lists 3 linked publications.
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 4 Jan 2023; AzTrials last refreshed its copy on 1 Nov 2026.