Tree Nut AllergyTITANNCT06038019
Thresholds In Food Allergy evaluaTion And predictioN
An observational study of Tree Nut Allergy and Food Allergy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors. Read more about this study
- Who is it for?
- Ages 3 months to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tree Nut Allergy, Food Allergy
- What is being tested?
- Oral food challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 2,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 1 Jan 2051
- How long will I take part?
- 1 Day
- 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 3 months to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All consecutive patients suspected or confirmed to be food allergic
Who may be able to join
- Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food.
- Ability to discontinue all antihistamines for 1 week before oral food challenge.
Who cannot join
- Previous desensitization treatment to a food allergen
- Allergies to any component of the oral challenge vehicle
- Unstable conditions including uncontrolled asthma or chronic urticaria
- Any clinically significant disease/chronic medical condition which may interfere with study evaluations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario
Heather Le
About this study
Official title: Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study
Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.
- Conditions
- Tree Nut Allergy, Food Allergy
- Being tested
- Oral food challenge
- Keywords
- Immunotherapy, Food Allergy, Diagnosis, Prognosis
- Medical subject headings
- Nut Hypersensitivity, Food Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challengeDiagnostic test
Patients will undergo oral food challenge with increasing amounts of food allergen
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with suspected or confirmed food allergy Receives: Diagnostic Test: Oral food challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eliciting dose thresholds to food challenge
Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria
Measured: 1 year
Secondary outcomes (7)
Food Allergy Quality of Life Questionnaire Child Form
The number of items found in the child form questionnaire includes 30 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
Measured: 1 year
Food Allergy Quality of Life Questionnaire Teen Form
The number of items found in the Teen Form questionnaire includes 26 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
Measured: 1 year
Food Allergy Quality of Life Questionnaire Adult Form
The number of items found in the Adult Form questionnaire includes 35 items. Food allergy quality of life questionnaire is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
Measured: 1 year
Food Allergy Quality of Life Questionnaire Parent Form
The number of items found in the Parent Form questionnaire includes 38 items. Food allergy quality of life questionnaire consists of 3 to 4 domains, each question is answered on a 7-point scale (0 to 6) with higher scores representing worse impairment.
Measured: 1 year
Skin Prick Testing
Measured by mean wheal size (mm)
Measured: 1 year
Specific IgE
Measured by ImmunoCap (kU/L)
Measured: 1 year
Basophil Activation Test
Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2050 (estimated)
- Study completion1 Jan 2051 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tree Nut AllergyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- AAAAI Foundation, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Derek Chu, MD PhD FRCPC, Principal investigator, Hamilton Health Sciences & McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038019
- Sponsor's protocol ID
- NIF-20500
- Acronym
- TITAN
- Status last verified
- May 2024
- First submitted
- 18 Aug 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will consider on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study
- ClinicalTrials.gov ID
- NCT06038019
- Acronym / sponsor ID
- TITAN / NIF-20500
- Conditions
- Tree Nut Allergy, Food Allergy
- Keywords
- Immunotherapy, Food Allergy, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- AAAAI Foundation, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2050 (estimated)
- Study completion
- 1 Jan 2051 (estimated)
- First posted
- 14 Sep 2023 (actual)
- 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.
Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Oral food challengePatients with suspected or confirmed food allergy |
Who may qualify
- Ages
- 3 months to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients suspected or confirmed to be food allergic
Key inclusion criteria (2 listed)
- Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food.
- Ability to discontinue all antihistamines for 1 week before oral food challenge.
Key exclusion criteria (4 listed)
- Previous desensitization treatment to a food allergen
- Allergies to any component of the oral challenge vehicle
- Unstable conditions including uncontrolled asthma or chronic urticaria
- Any clinically significant disease/chronic medical condition which may interfere with study evaluations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral food challengePatients will undergo oral food challenge with increasing amounts of food allergen | Diagnostic test | Group 1 |
Primary outcome
Eliciting dose thresholds to food challenge
Time frame: 1 year
Threshold are measured by controlled food challenge to incremental doses of allergen (g) and are adjudicated according to CoFAR v3.0 criteria
7 secondary outcomes
Food Allergy Quality of Life Questionnaire Child Form
Time frame: 1 year
Food Allergy Quality of Life Questionnaire Teen Form
Time frame: 1 year
Food Allergy Quality of Life Questionnaire Adult Form
Time frame: 1 year
Food Allergy Quality of Life Questionnaire Parent Form
Time frame: 1 year
Skin Prick Testing
Time frame: 1 year
Specific IgE
Time frame: 1 year
Basophil Activation Test
Time frame: 1 year
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 3 Jun 2024.
- Individual participant dataSharing planned: No. Will consider on a case by case basis.
Related trials for Tree Nut Allergy
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Study of Oral Food Challenge Biomarkers (SAFER)
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EPAP, Interviewstudy
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Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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UNC Cashew Sublingual Immunotherapy
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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.
Derek Chu, MD PhD FRCPC principal investigator
Hamilton Health Sciences & McMaster University
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 Tree Nut Allergy and Food Allergy, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 4 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 3 Jun 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 Canada. 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 Heather Le (905-525-9140 ext. 75153, lehea@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eliciting dose thresholds to food challenge (time frame: 1 year). 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 3 Jun 2024.