Evaluation of Allergy to Potato in a Large Cohort | NCT02893839

Studies
Evaluation of Allergy to Potato in a Large Cohort

NCT02893839

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Sep 9, 2016Estimated

Enrollment

2,000Actual

Phase

Not Applicable

Conditions

Allergy

Interventions

Prick to prick test

Countries

France

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Sep 2, 2016

First Posted Date

Sep 9, 2016Estimated

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

Sep 2, 2016

Last Update Posted Date

Sep 9, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Label	Type	Description	Intervention Names
Prick to prick	Other		Other: Prick to prick test

Name	Type	Description	Arm Group Labels	Other Names
Prick to prick test	Other		Prick to prick

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of sensitization and allergy to potato		35 months after the first inclusion

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Montpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D000099072	Oral Allergy Syndrome

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided