CompletedNot Applicable

Applying Systems Immunology to the Search for Personalized Biomarkers of Clinical Efficacy

Luxembourg50 participantsStarted 2016-08

Plain-language summary

Study Objective: Allergies affect up to 20% of the population of developed countries and can cause substantial individual disease burden. For some allergies, immunotherapeutic regimens ("hyposensitization") have been established, e.g. for insect venom allergies and pollen allergies. This project aims at identifying the T cell activation potential in vivo from resting T cells of patients undergoing immunotherapy (IT) via a systems biology approach. For the participants, it involves blood draws and stool collection as well as gathering some basic medical information. The participation takes one week for patients undergoing insect venom IT and three months for patients undergoing pollen IT. A control group without a clinical history of allergies is recruited. Blood and stool samples are collected in the same time frames as in allergic patients. This study is a cooperation project between the Centre Hospitalier de Luxembourg (CHL), the Luxemburg Institute of Health (LIH), the University of Luxembourg and the Integrated Biobank of Luxemburg (IBBL).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients undergoing subcutaneous immunotherapy for insect venom or pollen allergy Exclusion Criteria: * patients \< 18 years * medical conditions preventing patients in participating in the immunotherapy * lack of consent or lack to give consent to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predicting the effectiveness of immunotherapy against insect venom and pollens in allergic patients with use of gene expression networks.

Timeframe: Through study completion, an average of 1.5 years/April 2018

Trial details

NCT IDNCT02931955

SponsorLuxembourg Institute of Health

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2018-05-02

View on ClinicalTrials.gov More Allergy trials