Objective of the study is to compare the gene expression profiles of patients who experienced a re-systemic reaction at a re-sting in spite of completing venom immunotherapy with patients who did not react at a re-sting after stopping VIT. Theā¦
ID
Bron
Verkorte titel
Aandoening
- Allergische aandoeningen
Synoniemen aandoening
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main parameter of the study is the gene expression profile which may
predict the long term effect of venom immunotherapy.
Secundaire uitkomstmaten
1. The secondary parameter is the gene expression profile which will be
specific for patients with the highest risk at a systemic reaction at a resting
* before insect venom immunotherapy?
2. The tertiary parameter is the gene expression profile specific for patients
with the lowest risk of the systemic reaction to insect sting at the end of
maintenance phase of VIT?
Achtergrond van het onderzoek
Rationale: Insect venom allergy (defined as at least one life systemic reaction
in lifetime) is present in approximately 1-3% of population [1]. The treatment
of choice in insect venom allergy (IVA) patients is immunotherapy with purified
insect venom (VIT). Before treatment the risk at a systemic reaction to a
subsequent sting is 70% and will be reduced to 3% after reaching maintenance
dose [5]. After stopping VIT the risk at a re-systemic reaction increases in
some patients with time, in others it remains low. Unfortunately it is not
possible to predict long term efficacy in the individual patient so far.
Doel van het onderzoek
Objective of the study is to compare the gene expression profiles of patients
who experienced a re-systemic reaction at a re-sting in spite of completing
venom immunotherapy with patients who did not react at a re-sting after
stopping VIT. The additional aim is to compare changes in gene expression
before and after VIT.
Onderzoeksopzet
Comparison of differences in gene expression profiles between patients with
different risk profiles.
Inschatting van belasting en risico
The proposed study has no risks for the health of investigated individuals.
The burden for patients in group 1 and 2 is related to the unscheduled visit in
the outpatient department; therefore travel cost compensation is planned.
The burden for patients in group 3 and 4 is minimal because the blood samples
will be taken as a routine procedure.
The benefit for patients is different with respect to the different patient
groups. Subjects with a reaction after re-sting may prolong the immunotherapy
or increase the dose of allergen used to gain better protection from systemic
reactions after resting.
Remaining subjects will be informed about the results of the gene expression
profile.
The results of the study might be important for the assessment of the risk of
insect sting anaphylaxis and to advice on preventive methods to the individual
patients.
Algemeen / deelnemers
Hanzeplein 1
9700 RB Groningen
Nederland
Wetenschappers
Hanzeplein 1
9700 RB Groningen
Nederland
Landen waar het onderzoek wordt uitgevoerd
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
see in english
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
see in english
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
CCMO | NL26199.042.08 |