NCT00806364

Normal Blood, Bone Marrow and Buccal Mucosa Protocol

Completed Last updated 4 January 2023

What this trial tests

trial in Non-atopic in 119 participants. Completed in 3 November 2022.

Timeline

26 March 2009

Primary endpoint
2 January 2021

3 November 2022

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	119
Start date	26 March 2009
Primary completion	2 January 2021
Estimated completion	3 November 2022
Sites	1 location across United States

Conditions studied

• Non-atopic — all drugs for Non-atopic →
• Atopic — all drugs for Atopic →
• Healthy — all drugs for Healthy →
• Normal — all drugs for Normal →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 65, any sex, with Non-atopic or Atopic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Elevated basal serum tryptase identifies a multisystem disorder associated with increased TPSAB1 copy number.
   Lyons JJ, Yu X, Hughes JD, Le QT, et al · · 2016 · cited 294× · PMID 27749843 · DOI 10.1038/ng.3696
2. A distinct biomolecular profile identifies monoclonal mast cell disorders in patients with idiopathic anaphylaxis.
   Carter MC, Desai A, Komarow HD, Bai Y, et al · · 2018 · cited 81× · PMID 28629749 · DOI 10.1016/j.jaci.2017.05.036
3. mTORC1 and mTORC2 differentially regulate homeostasis of neoplastic and non-neoplastic human mast cells.
   Smrz D, Kim MS, Zhang S, Mock BA, et al · · 2011 · cited 45× · PMID 22053105 · DOI 10.1182/blood-2011-06-359984
4. Selective immunocapture reveals neoplastic human mast cells secrete distinct microvesicle- and exosome-like populations of KIT-containing extracellular vesicles.
   Pfeiffer A, Petersen JD, Falduto GH, Anderson DE, et al · · 2022 · cited 20× · PMID 36239715 · DOI 10.1002/jev2.12272
5. KIT GNNK splice variants: expression in systemic mastocytosis and influence on the activating potential of the D816V mutation in mast cells.
   Chan EC, Bai Y, Bandara G, Simakova O, et al · · 2013 · cited 14× · PMID 23743299 · DOI 10.1016/j.exphem.2013.05.005
6. sCD14 and Intestinal Fatty Acid Binding Protein Are Elevated in the Serum of Patients With Idiopathic Anaphylaxis.
   Cao VT, Carter MC, Brenchley JM, Bolan H, et al · · 2023 · cited 7× · PMID 36997122 · DOI 10.1016/j.jaip.2023.03.037
7. Distinct CRTH2+CD161+ (peTh2) memory CD4+ T-cell cytokine profiles in food allergy and eosinophilic gastrointestinal disorders.
   Makiya MA, Brown T, Holland N, Wetzler L, et al · · 2023 · cited 6× · PMID 37487654 · DOI 10.1111/cea.14376