NCT05826405

Brief Summary

The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

April 7, 2023

Last Update Submit

April 21, 2023

Conditions

Allergy;FoodAllergy, Nut

Keywords

allergyfood allergycashew nut allergyoral immunotherapypistachio allergy

Outcome Measures

Primary Outcomes (1)

  • Number of allergic reaction

    during 6 months

Secondary Outcomes (8)

  • Predictive factor of good tolerance

    during 6 months

  • antibody variation

    during 6 months

  • sustained unresponsiveness

    9 months

  • oral tolerance of pistachio

    6 months

  • Predictive factor of good tolerance

    6 months

  • +3 more secondary outcomes

Study Arms (1)

Cashew Nut allergic

Other: No intervention

Interventions

No interventionOTHER

No intervention, it's an observational study

Cashew Nut allergic

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients from 0 to 18 years old followed in allergology at the University Hospital of Nancy benefiting from oral immunotherapy with cashew nuts for at least 18 months as of 02/28/2023

You may qualify if:

  • Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.
  • Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023

You may not qualify if:

  • Patients who have received oral cashew nut immunotherapy for less than 18 months.
  • Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Food HypersensitivityNut HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System DiseasesNut and Peanut Hypersensitivity

Central Study Contacts

Amandine AD DIVARET-CHAUVEAU, MCU PH

CONTACT

+3383153695a.chauveau@chru-nancy.fr

Study Design

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

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 24, 2023

Study Start

May 10, 2023

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04