NCT02893839

Brief Summary

Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever suspicion of allergy were asked to participate in the study. Besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

August 11, 2016

Last Update Submit

September 2, 2016

Conditions

Allergy

Keywords

Allergycross-reactivityoral allergy syndromepotatosensitization

Outcome Measures

Primary Outcomes (1)

  • Rate of sensitization and allergy to potato

    35 months after the first inclusion

Secondary Outcomes (2)

  • Rate of risk factors of sensitization to raw potato

    35 months after the first inclusion

  • Rate of risk factors of sensitization to cooked potato

    35 months after the first inclusion

Study Arms (1)

Prick to prick

OTHER
Other: Prick to prick test

Interventions

Prick to prick testOTHER
Prick to prick

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 2 years or older
  • consent obtained from patients or their parents/legal representative

You may not qualify if:

  • refusal to participate in the study
  • antihistamine drugs taken before testing
  • pregnant women
  • vulnerable patients according to French regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

HypersensitivityOral Allergy Syndrome

Condition Hierarchy (Ancestors)

Immune System DiseasesFood HypersensitivityHypersensitivity, Immediate

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 9, 2016

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

FR(1)