Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Applying Systems Immunology to the Search for Personalized Biomarkers of Clinical Efficacy (SYS-T-ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02931955
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Integrated Biobank of Luxembourg
Centre Hospitalier du Luxembourg
Information provided by (Responsible Party):
Sebastian Bode, MD, Luxembourg Institute of Health

Brief 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.

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).


Condition or disease Intervention/treatment
Allergy Other: Blood draw, stool collection.

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Applying Systems Immunology to the Search for Personalized Biomarkers of Clinical Efficacy: Predicting the T Cell Activation Potential in Vivo From Resting T Cells of Patients
Study Start Date : August 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Venom Group

The investigators plan to include 15 patients with insect venom allergy and will collect blood at four time points and stool at three time points during the first week of immunotherapy.

The patients will receive usual standard of care and no intervention. We will, however, include blood draw and stool samples collection from the patients.

Other: Blood draw, stool collection.
Blood will be drawn by certified personnel according to local regulations. Stool will be collected by the patients after instructions on how to use a stool collection kit.

Pollen Group

The investigators plan to include 15 patients with pollen allergy and will collect blood at five time points and stool at three time points during the first three months of immunotherapy.

The patients will receive usual standard of care and no intervention. We will, however, include blood draw and stool samples collection from the patients.

Other: Blood draw, stool collection.
Blood will be drawn by certified personnel according to local regulations. Stool will be collected by the patients after instructions on how to use a stool collection kit.




Primary Outcome Measures :
  1. Predicting the effectiveness of immunotherapy against insect venom and pollens in allergic patients with use of gene expression networks. [ Time Frame: Through study completion, an average of 1.5 years/April 2018 ]

    This study will allow to predict the T cell activation potential (by evaluating gene expression networks) in vivo before start of immunotherapy for insect venom or pollen allergy meaning that the investigators will be able to predict which patients will profit from standard immunotherapy and which patients will need to receive altered immunotherapy strategies (i.e. higher doses, longer maintenance).

    As this is an observational pilot study the investigators define this as outcome measure.



Biospecimen Retention:   Samples With DNA
Both lymphocytes and stool samples of the patients will be retained.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will recruit participants from the allergy referral center at the CHL Luxembourg who are undergoing immunotherapy for insect venom or pollen allergy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931955


Locations
Layout table for location information
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210
Sponsors and Collaborators
Luxembourg Institute of Health
Integrated Biobank of Luxembourg
Centre Hospitalier du Luxembourg
Investigators
Layout table for investigator information
Principal Investigator: Markus Ollert, Prof. Luxembourg Institute of Health
Principal Investigator: Feng Q He, PhD Luxembourg Institute of Health

Layout table for additonal information
Responsible Party: Sebastian Bode, MD, Clinician Scientist, Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT02931955     History of Changes
Other Study ID Numbers: SYS-T-ACT_01
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sebastian Bode, MD, Luxembourg Institute of Health:
allergy
insect venom
pollen
systems biology