AllergyNCT02893839
Evaluation of Allergy to Potato in a Large Cohort
A study testing Prick to prick test in people with Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Prick to prick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients aged 2 years or older
- consent obtained from patients or their parents/legal representative
Who cannot join
- refusal to participate in the study
- antihistamine drugs taken before testing
- pregnant women
- vulnerable patients according to French regulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Sensitization to Potato in Patients Consulting at the Allergy Unit in Montpellier
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.
- Conditions
- Allergy
- Being tested
- Prick to prick test
- Keywords
- Allergy, cross-reactivity, oral allergy syndrome, potato, sensitization
- Medical subject headings
- Hypersensitivity, Oral Allergy Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prick to prick testOther
| Study group | Role | What they receive |
|---|---|---|
| Prick to prick | Other | Not described Receives: Other: Prick to prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of sensitization and allergy to potato
Measured: 35 months after the first inclusion
Secondary outcomes (2)
Rate of risk factors of sensitization to raw potato
Measured: 35 months after the first inclusion
Rate of risk factors of sensitization to cooked potato
Measured: 35 months after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893839
- Sponsor's protocol ID
- UF 9045
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sensitization to Potato in Patients Consulting at the Allergy Unit in Montpellier
- ClinicalTrials.gov ID
- NCT02893839
- Acronym / sponsor ID
- UF 9045
- Conditions
- Allergy
- Keywords
- Allergy, cross-reactivity, oral allergy syndrome, potato, sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prick to prick | Other | Other: Prick to prick test |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 2 years or older
- consent obtained from patients or their parents/legal representative
Key exclusion criteria (4 listed)
- refusal to participate in the study
- antihistamine drugs taken before testing
- pregnant women
- vulnerable patients according to French regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prick to prick test | Other | Prick to prick |
Primary outcome
Rate of sensitization and allergy to potato
Time frame: 35 months after the first inclusion
2 secondary outcomes
Rate of risk factors of sensitization to raw potato
Time frame: 35 months after the first inclusion
Rate of risk factors of sensitization to cooked potato
Time frame: 35 months after the first inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prick to prick test in people with Allergy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of sensitization and allergy to potato (time frame: 35 months after the first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.