NCT04407104

Brief Summary

Allergy to tree nuts are frequent in children but allergy to almond is one of the less described tree nuts allergy. The main objective of our study is to determine diagnostic values of skin prick-tests and specific IgE to almond in a population of children sensitized to almond and challenged in our unit from november 2013 to march 2020.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

May 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
Last Updated

July 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 25, 2020

Last Update Submit

July 20, 2020

Conditions

Keywords

almondtree nutsatopyallergychildren

Outcome Measures

Primary Outcomes (1)

  • diagnostic values of skin prick-test and sIgE to almond

    BASELINE

Secondary Outcomes (3)

  • allergic reactions during oral food challenge

    BASELINE

  • eliciting doses to almond

    BASELINE

  • atopic comorbidities

    BASELINE

Interventions

skin prick-testDIAGNOSTIC_TEST

retrospective study on data already collected

Also known as: specific IgE, oral food challenge

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children sensitized to almond and challenged in our unit

You may qualify if:

  • oral food challenge to almond performed in the pediatric allergy department of the University Hospital of Nancy from november 2013 and march 2020

You may not qualify if:

  • doubtful or incomplete oral food challenge to almond

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 29, 2020

Study Start

July 20, 2020

Primary Completion

August 31, 2020

Study Completion

September 7, 2020

Last Updated

July 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share