Clinical Cross Reactions Between Anacardiaceae (Cross-Anacards)

June 4, 2020 updated by: University Hospital, Montpellier

Evaluating the Correlation Between the Results of the Allergy Work-up for Different Allergens of the Anacardiaceae Family

The prevalence of food allergies has increased in recent decades, ranging from 1 to 3% of the general population. According to international literature and French national surveys, nuts today represent a group of allergens often associated with severe allergic reactions. They are responsible for 18 to 40% of deaths from food-related anaphylaxis.

Among all nuts, the prevalence of anacardiac allergies (mainly cashew and pistachio) continues to increase and has become a growing public health problem. Today, global production is estimated at 4.9 million tonnes of cashews and 1.1 million tonnes of pistachios. The resulting increased exposure may explain the increased prevalence of allergic reactions reported to these fruits. In addition, anaphylactic reactions to anacardiaceae are reported to be even more severe than those occurring in subjects allergic to peanuts.

Cashews and pistachios are known to exhibit immunological cross-reactions with one another. In fact, they have a strong sequential homology between their storage allergens Ana o 1 / Pis v 3 (7S vicilin, 78% homology); Ana o 2 / Pis v 2 (legume 11S, 80% homology) and Ana o 3 / Pis v 1 (albumin 2S, 70% homology). For this reason, some authors talk about the cashew / pistachio syndrome and associate the two allergenic sources by considering them as one, in clinical practice.

The diagnosis of allergy to nuts, and therefore to anacardiaceae, is based on a compatible clinical history, the presence of specific IgE (demonstrated by positivity to realistic skin tests and serum IgE assay), and positivity on the oral food challenge test.

In clinical practice, taking into account the cashew / pistachio syndrome, when the allergy work-up for cashew is negative, allergists tend to advise to reintroduce pistachio at home, considering the two allergens as sufficiently homologous to authorize such a practice. In this context, the investigators decided to check whether this practice, which is based mainly on in vitro homologies, is risk-free, based on the clinical experience of our center.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

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Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients consulting at the Allergy Unit of the University Hospital of Montpellier (France) for a suspected food allergy to Anacardiaceae

Description

Inclusion criteria:

  • Patient evaluated at the Allergy Unit of the University Hospital of Montpellier (France)
  • Suspicion of food allergy to Anacardiaceae
  • Allergy work-up for cashew and pistachio including at least skin tests, and possible specific IgE and food challenge

Exclusion criteria:

- Patients included in other trials that don't allow them to be included in the present one

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PPV and NPV
Time Frame: 1 day
PPV and NPV of the results of skin tests and food challenge to either cashew or pistachio to predict a concordant result for pistachio or cashew, respectively
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative risk
Time Frame: 1 day
Finding risk factors predictive of discrepancies between the results of the allergy work-up for cashew and pistachio
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Davide CAIMMI, University Hospital, Montpellier

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL20_0151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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