Peanut AllergiesNCT02192866
Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
An observational study of Peanut Allergies and Tree Nut Allergies, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies. Read more about this study
- Who is it for?
- Ages 1 year to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peanut Allergies, Tree Nut Allergies, Other Food Allergies
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2030
- 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 1 year to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children who are allergic to peanuts and/or tree-nuts and individuals with no known food allergies.
Who may be able to join
- This protocol is to draw blood for a variety of related studies of food allergy. For this reason, we will list each group of subjects and the inclusion criteria for that group.
- De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.
- patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge.
- Age 1-75.
- De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
- concern regarding possible allergy to peanuts,
Show all 18Show fewer
- age 1-75,
- plan to undergo a clinically indicated challenge with peanuts.
- Patients with peanut allergy.
- excellent history of a systemic reaction to peanuts,
- age 6-75.
- Patients with other food allergies (especially tree nuts).
- excellent history of a systemic reaction to tree nuts or other foods,
- age 6-75.
- Normal controls.
- no known food allergies,
- recent ingestion of peanuts without difficulty, and
- age 6-75.
Who cannot join
- Any known significant medical or psychiatric diagnosis
- Use of an investigational drug within 30 days
- Use of omalizumab (anti-IgE; Xolair) within 6 months
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, 1 recruiting
- Recruiting
University of Colorado School of Medicine
Denver, Colorado, 80045
Stephen C Dreskin, 303-877-2754, stephen.dreskin@cuanschutz.edu
About this study
Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies.
Samples will come from:
Read more
- People signed up by the investigators at the University of Colorado Denver
- University of North Carolina, Massachusetts General Hospital, Children's Hospital of Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people have been treated for peanut allergies
- University of North Carolina, Massachusetts General Hospital, National Jewish Health and The Children's Hospital in Denver where people have taken part or will take part in clinically indicated oral food challenges.
Blood and health histories from the University of North Carolina, Massachusetts General Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network will not have personal information linked.
The specific aims of this experiment are:
- Come up with a lab test that will predict how bad an allergic reaction will be to peanuts.
- Find out what part of a peanut causes allergic reactions.
- Come up with preventions that can block peanut allergies.
- Find the strongest proteins in walnuts.
Read the detailed description
Overview: This is a protocol for obtaining serum, plasma, and cells from subjects with specific food allergies and from controls to be used in studies of peanut and other allergens. We are only asking the CTRC for help with drawing blood, separating serum, labeling tubes and to aliquot the serum. In addition, we will receive de-identified serum and plasma from other institutions and de-identified cord blood from the University of Colorado Denver Cord Blood bank.
The previous version of this application was COMIRB protocol 09-0813. This was last updated 03-03-2016. Much of the work outlined in protocol 09-0813 was completed and a manuscript is under review. This protocol is still only for the purpose of drawing blood and obtaining clinical histories. As such the risks and benefits in the informed consent have not changed.
Based on new NIH funding (RO3 AI 164349; started 7-09-21) and RO1-AI165866 (9th %-tile; scheduled to begin 09-01-21), the project now includes 5 specific aims (Aims #1-5). Aims 1 \& 2 are part of an R21 funded project (R21 AI135397; 11/16/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Dreskin. Aims 3 \& 4 are part of an R21 funded project (R21 AI137881; 11/28/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Chen (Dr. Dreskin is Co-PI). These proposals are highly complementary and each only needs access to blood samples. Dr. Dreskin's proposal consists of in vitro experiments to test IgE binding to novel peptides. Dr. Chen's proposal uses human serum or plasma as a source of IgE with which to identify and characterize mimotopes for murine studies. Aim 5 is an exploratory aim to obtain preliminary data for an RO1 to be submitted in 2019. For all of these projects, the only experiments that involve human materials are ex vivo assays of basophil activation, in vitro assays of IgE binding and generation of humanized mice using de-identified cord blood that will otherwise be discarded. There are no therapeutic interventions for human subjects.
- Conditions
- Peanut Allergies, Tree Nut Allergies, Other Food Allergies
- Medical subject headings
- Peanut Hypersensitivity, Nut 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 |
|---|---|---|
| Peanut allergic | No intervention(s) to be administered. | |
| Other food allergic | No intervention(s) to be administered. | |
| Controls | No intervention(s) to be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify which traits are associated with severe food allergy.
This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.
Measured: 1 day of single blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergiesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephen Dreskin, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192866
- Sponsor's protocol ID
- 13-2102
- Other IDs
- UL1TR001082
- Status last verified
- Dec 2022
- First submitted
- 24 Feb 2014
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dreskin SC, Koppelman SJ, Andorf S, Nadeau KC, Kalra A, Braun W, Negi SS, Chen X, Schein CH. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163. doi: 10.1016/j.jaci.2020.11.004. Epub 2020 Nov 18.
PubMed 33217410Hazebrouck S, Patil SU, Guillon B, Lahood N, Dreskin SC, Adel-Patient K, Bernard H. Immunodominant conformational and linear IgE epitopes lie in a single segment of Ara h 2. J Allergy Clin Immunol. 2022 Jul;150(1):131-139. doi: 10.1016/j.jaci.2021.12.796. Epub 2022 Feb 10.
PubMed 35150723Hazebrouck S, Canon N, Dreskin SC. The Effector Function of Allergens. Front Allergy. 2022 Feb 7;3:818732. doi: 10.3389/falgy.2022.818732. eCollection 2022.
PubMed 35386644Dreskin SC, Germinaro M, Reinhold D, Chen X, Vickery BP, Kulis M, Burks AW, Negi SS, Braun W, Chambliss JM, Eglite S, McNulty CMG. IgE binding to linear epitopes of Ara h 2 in peanut allergic preschool children undergoing oral Immunotherapy. Pediatr Allergy Immunol. 2019 Dec;30(8):817-823. doi: 10.1111/pai.13117. Epub 2019 Oct 21.
PubMed 31437325
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Samples for the Study of Peanut, Tree Nut and Other Food Allergies
- ClinicalTrials.gov ID
- NCT02192866
- Acronym / sponsor ID
- 13-2102
- Conditions
- Peanut Allergies, Tree Nut Allergies, Other Food Allergies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Jul 2014 (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.
Food allergies are now a major problem. These experiments involve getting blood from people with food allergies and from people without food allergies. The blood collected will be used to answer questions and find information about peanut and other food allergies.
Samples will come from:
- People signed up by the investigators at the University of Colorado Denver
- University of North Carolina, Massachusetts General Hospital, Children's Hospital of Colorado and the Immune Tolerance Network (Benaroya Research Institute) where people have been treated for peanut allergies
- University of North Carolina, Massachusetts General Hospital, National Jewish Health and The Children's Hospital in Denver where people have taken part or will take part in clinically indicated oral food challenges.
Blood and health histories from the University of North Carolina, Massachusetts General Hospital, National Jewish Health, The Children's Hospital and the Immune Tolerance Network will not have personal information linked.
The specific aims of this experiment are:
- Come up with a lab test that will predict how bad an allergic reaction will be to peanuts.
- Find out what part of a peanut causes allergic reactions.
- Come up with preventions that can block peanut allergies.
- Find the strongest proteins in walnuts.
Detailed description
Overview: This is a protocol for obtaining serum, plasma, and cells from subjects with specific food allergies and from controls to be used in studies of peanut and other allergens. We are only asking the CTRC for help with drawing blood, separating serum, labeling tubes and to aliquot the serum. In addition, we will receive de-identified serum and plasma from other institutions and de-identified cord blood from the University of Colorado Denver Cord Blood bank.
The previous version of this application was COMIRB protocol 09-0813. This was last updated 03-03-2016. Much of the work outlined in protocol 09-0813 was completed and a manuscript is under review. This protocol is still only for the purpose of drawing blood and obtaining clinical histories. As such the risks and benefits in the informed consent have not changed.
Based on new NIH funding (RO3 AI 164349; started 7-09-21) and RO1-AI165866 (9th %-tile; scheduled to begin 09-01-21), the project now includes 5 specific aims (Aims #1-5). Aims 1 \& 2 are part of an R21 funded project (R21 AI135397; 11/16/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Dreskin. Aims 3 \& 4 are part of an R21 funded project (R21 AI137881; 11/28/2018-10/31/2020; extended until 10/31/2021 without additional funds) to Dr. Chen (Dr. Dreskin is Co-PI). These proposals are highly complementary and each only needs access to blood samples. Dr. Dreskin's proposal consists of in vitro experiments to test IgE binding to novel peptides. Dr. Chen's proposal uses human serum or plasma as a source of IgE with which to identify and characterize mimotopes for murine studies. Aim 5 is an exploratory aim to obtain preliminary data for an RO1 to be submitted in 2019. For all of these projects, the only experiments that involve human materials are ex vivo assays of basophil activation, in vitro assays of IgE binding and generation of humanized mice using de-identified cord blood that will otherwise be discarded. There are no therapeutic interventions for human subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peanut allergic | – | –No intervention(s) to be administered. |
| Other food allergic | – | –No intervention(s) to be administered. |
| Controls | – | –No intervention(s) to be administered. |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children who are allergic to peanuts and/or tree-nuts and individuals with no known food allergies.
Key inclusion criteria (18 listed)
- This protocol is to draw blood for a variety of related studies of food allergy. For this reason, we will list each group of subjects and the inclusion criteria for that group.
- De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.
- De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
- Patients with peanut allergy.
- Patients with other food allergies (especially tree nuts).
Key exclusion criteria (3 listed)
- Any known significant medical or psychiatric diagnosis
- Use of an investigational drug within 30 days
- Use of omalizumab (anti-IgE; Xolair) within 6 months
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
Identify which traits are associated with severe food allergy.
Time frame: 1 day of single blood draw
This is an observational study, to describe traits (identified through blood tests) associated with severe food allergy, particularly peanut allergy.
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 19 Dec 2022.
- Results publication: PubMed 33217410Dreskin SC, Koppelman SJ, Andorf S, Nadeau KC, Kalra A, Braun W, Negi SS, Chen X, Schein CH. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163. doi: 10.1016/j.jaci.2020.11.004. Epub 2020 Nov 18.
- Results publication: PubMed 35150723Hazebrouck S, Patil SU, Guillon B, Lahood N, Dreskin SC, Adel-Patient K, Bernard H. Immunodominant conformational and linear IgE epitopes lie in a single segment of Ara h 2. J Allergy Clin Immunol. 2022 Jul;150(1):131-139. doi: 10.1016/j.jaci.2021.12.796. Epub 2022 Feb 10.
- Results publication: PubMed 35386644Hazebrouck S, Canon N, Dreskin SC. The Effector Function of Allergens. Front Allergy. 2022 Feb 7;3:818732. doi: 10.3389/falgy.2022.818732. eCollection 2022.
- Results publication: PubMed 31437325Dreskin SC, Germinaro M, Reinhold D, Chen X, Vickery BP, Kulis M, Burks AW, Negi SS, Braun W, Chambliss JM, Eglite S, McNulty CMG. IgE binding to linear epitopes of Ara h 2 in peanut allergic preschool children undergoing oral Immunotherapy. Pediatr Allergy Immunol. 2019 Dec;30(8):817-823. doi: 10.1111/pai.13117. Epub 2019 Oct 21.
- Individual participant dataSharing planned: No
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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.
Stephen Dreskin, MD, PhD principal investigator
University of Colorado, Denver
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 Peanut Allergies and Tree Nut Allergies, run by University of Colorado, Denver 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 18 inclusion and 3 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 19 Dec 2022. 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 Stephen Dreskin, MD, PhD (303-724-7190, Stephen.Dreskin@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify which traits are associated with severe food allergy. (time frame: 1 day of single blood draw). 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 NCT02192866, which also lists 4 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 19 Dec 2022.