Thresholds In Food Allergy evaluaTion And predictioN (TITAN)

• ClinicalTrials.gov Identifier: NCT06038019
• Recruitment Status: Recruiting
• First Posted: September 14, 2023
• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: AAAAI Foundation; Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Hamilton Health Sciences Corporation

Tracking Information

• First Submitted Date: August 18, 2023
• First Posted Date: September 14, 2023
• Last Update Posted Date: June 3, 2024
• Actual Study Start Date: November 1, 2023
• Estimated Primary Completion Date: November 1, 2050 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 7, 2023)

• Food Allergy Quality of Life Questionnaire Child Form [ Time Frame: 1 year ]
  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.
• Food Allergy Quality of Life Questionnaire Teen Form [ Time Frame: 1 year ]
  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.
• Food Allergy Quality of Life Questionnaire Adult Form [ Time Frame: 1 year ]
  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.
• Food Allergy Quality of Life Questionnaire Parent Form [ Time Frame: 1 year ]
  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.
• Skin Prick Testing [ Time Frame: 1 year ]
  Measured by mean wheal size (mm)
• Specific IgE [ Time Frame: 1 year ]
  Measured by ImmunoCap (kU/L)
• Basophil Activation Test [ Time Frame: 1 year ]
  Measured by flow cytometry (cell frequency basophils and median fluorescence intensity)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Thresholds In Food Allergy evaluaTion And predictioN
• Official Title: Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 1 Day
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All consecutive patients suspected or confirmed to be food allergic

Condition

• Tree Nut Allergy
• Food Allergy

Intervention

Diagnostic Test: Oral food challenge

Patients will undergo oral food challenge with increasing amounts of food allergen

Study Groups/Cohorts

Group 1

Patients with suspected or confirmed food allergy

Intervention: Diagnostic Test: Oral food challenge

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 7, 2023): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2051
• Estimated Primary Completion Date: November 1, 2050 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. 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.
2. Ability to discontinue all antihistamines for 1 week before oral food challenge.

Exclusion Criteria:

1. Previous desensitization treatment to a food allergen
2. Allergies to any component of the oral challenge vehicle
3. Unstable conditions including uncontrolled asthma or chronic urticaria
4. Any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 65 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Heather Le; 905-525-9140 ext 75153; lehea@hhsc.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT06038019
• Other Study ID Numbers: NIF-20500
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Will consider on a case by case basis.

• Current Responsible Party: Hamilton Health Sciences Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Hamilton Health Sciences Corporation
• Original Study Sponsor: Same as current

Collaborators

• AAAAI Foundation
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Derek Chu, MD PhD FRCPC; Hamilton Health Sciences & McMaster University

• PRS Account: Hamilton Health Sciences Corporation
• Verification Date: May 2024