AllergyCytovenNCT00805402
Interest of Flow Cytometry for the Diagnosis, the Follow up and Specific Immunotherapy (SIT) Arrest of Hymenoptera Venom Allergy
A study testing flow cytometry in people with Allergy, run by University Hospital, Limoges at 1 site in France.
Trial summary
The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy. 75 patients having a story of reaction to hymenoptera venom will be selected for this trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergy
- What is being tested?
- flow cytometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2008to Jul 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (18 - 70 years)
- Patient being informed and accepting to participate in the study with signature of informed consent
- Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.
- Patients treated by SIT for at least 5 years
- Patients benefiting from a national insurance health
Who cannot join
- Children
- Pregnant woman or who breast-feed
- Patient under antihistaminic or corticoid for less than 8 days before the blood drawing
- Protected Patient
- Patient not having given his agreement after it was informed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy
The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.
75 patients having a story of reaction to hymenoptera venom will be selected for this trial.
Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.
- Conditions
- Allergy
- Being tested
- flow cytometry
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flow cytometryOther
flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| 1 flow cytometry | Experimental | flow cytometry Receives: Other: flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
% CD63 expression on basophil membrane by flow Cytometry
Measured: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
Secondary outcomes (1)
Blood blocking factors level
Measured: Week 1, Week 3, Week 10 and Week 21 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel COGNE, MD, Principal investigator, CHU LimogesJean Sainte-Laudy, PhD, Study chair, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805402
- Sponsor's protocol ID
- I07021
- Acronym
- Cytoven
- Status last verified
- Sep 2010
- First submitted
- 2 Dec 2008
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sainte-Laudy J, Touraine F, Cluzan D, Belle Moudourou F. Follow-Up of Venom Immunotherapy on Flow Cytometry and Definition of a Protective Index. Int Arch Allergy Immunol. 2016;170(4):243-250. doi: 10.1159/000449162. Epub 2016 Sep 30.
PubMed 27685197
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Flow Cytometry for the Diagnosis, the Follow up and SIT Arrest of Hymenoptera Venom Allergy
- ClinicalTrials.gov ID
- NCT00805402
- Acronym / sponsor ID
- Cytoven / I07021
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Dec 2008 (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.
The aim of this study is to show that flow cytometry can be an accurate tool to help physicians regarding the diagnosis, the SIT decision and the SIT arrest of hymenoptera venom allergy.
75 patients having a story of reaction to hymenoptera venom will be selected for this trial.
Blood samples will be analyzed at: inclusion visit, Week 1 visit, Week 3 visit, Week 10 and Week 21 visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 flow cytometry | Experimental | Other: flow cytometryflow cytometry |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient (18 - 70 years)
- Patient being informed and accepting to participate in the study with signature of informed consent
- Patients having a clinical systematic and local, loco-regional story of reaction to the piqures of hymenopterans.
- Patients treated by SIT for at least 5 years
- Patients benefiting from a national insurance health
Key exclusion criteria (5 listed)
- Children
- Pregnant woman or who breast-feed
- Patient under antihistaminic or corticoid for less than 8 days before the blood drawing
- Protected Patient
- Patient not having given his agreement after it was informed
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 |
|---|---|---|
| flow cytometryflow cytometry | Other | 1 flow cytometry |
Primary outcome
% CD63 expression on basophil membrane by flow Cytometry
Time frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits
1 secondary outcome
Blood blocking factors level
Time frame: Week 1, Week 3, Week 10 and Week 21 visits
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 16 Jul 2025.
- Results publication: PubMed 27685197Sainte-Laudy J, Touraine F, Cluzan D, Belle Moudourou F. Follow-Up of Venom Immunotherapy on Flow Cytometry and Definition of a Protective Index. Int Arch Allergy Immunol. 2016;170(4):243-250. doi: 10.1159/000449162. Epub 2016 Sep 30.
Related trials for Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
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.
Michel COGNE, MD principal investigator
CHU Limoges
Jean Sainte-Laudy, PhD study chair
CHU Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flow cytometry in people with Allergy, run by University Hospital, Limoges 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 5 inclusion and 5 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 16 Jul 2025. 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?
% CD63 expression on basophil membrane by flow Cytometry (time frame: Inclusion , Week 1, Week 3, Week 10 and Week 21 visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805402, which also lists 1 linked publication.
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 16 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.