NCT06918249

Brief Summary

All children sensitized to lupine who have performed an oral food challenge (OFC) to lupine between January 2017 and May 2024 in the Pediatric Allergy Unit of the University Hospital of Nancy were included. Retrospective data regarding food and respiratory allergies were collected as well as information regarding lupine skin prick test (SPT), specific IgE (sIgE) and OFC. Severity of allergic reaction was evaluated by CoFAR grade and reactogenic cumulative threshold dose. Aims of this study were (i) to assess relevance of sensitization to lupine in children and (ii) to describe severity of reactions in case of allergy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

7.3 years

First QC Date

March 30, 2025

Last Update Submit

April 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • diagnostic value of prick test and specific IgE

    prick test to lupine flour in mm done during interview and collected retrospectively Specific IgE in kU/L to lupine seed done during same interview and collected retrospectively prick test and sIgE done as in usual clinical practice main outcome of the study are statistical tests (ROC curve) done to analyse diagnostic values of prick test and sIgE in this population

    baseline

Secondary Outcomes (1)

  • severity of allergic reaction in oral food challenge

    baseline

Interventions

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children under 18 years as the study was done in the Pediatric Allergy department

You may qualify if:

  • cutaneous or biological sensitization to lupine

You may not qualify if:

  • oral food challenge done with something other than lupine flour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 9, 2025

Study Start

January 1, 2017

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

April 9, 2025

Record last verified: 2025-04