Efficacy and Safety of Oral Cashew Nut Immunotherapy in C... | NCT05826405

Studies
Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO)

NCT05826405

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Apr 24, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Allergy;Food
Allergy, Nut

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2023Estimated

Primary Completion Date

May 10, 2023Estimated

Completion Date

May 10, 2023Estimated

First Submitted Date

Apr 7, 2023

First Submission Date that Met QC Criteria

Apr 21, 2023

First Posted Date

Apr 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2023

Last Update Posted Date

Apr 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amandine DIVARET-CHAUVEAU, Principal investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cashew Nut allergic			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention, it's an observational study	Cashew Nut allergic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of allergic reaction		during 6 months

Secondary Outcomes

Measure	Description	Time Frame
Predictive factor of good tolerance	age at onset	during 6 months
antibody variation	Modification of level of specific IgE and IGg4 with cashew nuts

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amandine AD DIVARET-CHAUVEAU, MCU PH	Contact	+3383153695		a.chauveau@chru-nancy.fr

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005512	Food Hypersensitivity
D021184	Nut Hypersensitivity
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases
D000074924	Nut and Peanut Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided