Primary Immunodeficiency DiseaseNCT01150240
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland
An observational study of Primary Immunodeficiency Disease, run by University of Zurich at 6 sites in Switzerland.
Trial summary
A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Immunodeficiency Disease
- How many people
- 800 participants
- Where
- 6 sitesSwitzerland
- Study dates
- Oct 2006to Dec 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice
Who may be able to join
- Primary Immunodeficiency Disease (PID)
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
University Hospital Basel
Basel
University Hospital Bern
Bern
University Children's Hospital Geneva
Geneva
University Hospital Lausanne
Lausanne
Children's Hospital of Eastern Switzerland and Cantonal Hospital
Sankt Gallen
University Children's Hospital Zurich
Zurich
About this study
A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).
Read the detailed description
The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients.
Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.
- Conditions
- Primary Immunodeficiency Disease
- Keywords
- Primary Immunodeficiency Disease
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Immunodeficiency Disease | Patients with primary Immunodeficiency disease (PID) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startOct 2006
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, University of Bern, University Hospital, Geneva, University of Lausanne, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Arthur Helbling, Prof., Principal investigator, University Bern, InselspitalChristoph Hess, Prof., Principal investigator, University Basel, University HospitalAyse H Ozsahin, Prof., Principal investigator, University Geneva, University HospitalFrancois Spertini, Prof., Principal investigator, University Lausanne, University HospitalHugo Ubieto, MD, Principal investigator, Department of Child Development, Children's Hospital St. Gallen, SwitzerlandReinhard A Seger, Prof., Principal investigator, University Zürich, University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150240
- Sponsor's protocol ID
- PID_CH_Registry06
- Status last verified
- May 2016
- First submitted
- 23 Jun 2010
- Last updated
- 13 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland
- ClinicalTrials.gov ID
- NCT01150240
- Acronym / sponsor ID
- PID_CH_Registry06
- Conditions
- Primary Immunodeficiency Disease
- Keywords
- Primary Immunodeficiency Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Basel, University of Bern, University Hospital, Geneva, University of Lausanne, Cantonal Hospital of St. Gallen
- Study start
- Oct 2006
- Primary completion
- Dec 2018 (estimated)
- First posted
- 24 Jun 2010 (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.
A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).
Detailed description
The project aims to compile clinical and laboratory data of patients with primary immunodeficiencies (PID) in order to improve diagnosis, classification, prognosis and therapy. The online technology offers features not available in former databases such as access control,security functionality, and maintenance of data integrity during transactions and system errors, online back up, online optimization, scalability and online SQL-queries as well as a long term documentation of patients.
Furthermore the database can be used for the submission and storage of molecular diagnostic results and thus allow the compilation of genotype and phenotype observations, which is of essential and immediate use for the patient himself and patient care. An attending physician may gain information on similar cases of a rare PID disease in Switzerland and European countries and use these insights for therapy. In addition, it will be possible to obtain an insight on side effects. Thus, the system also meets the requirements of an optimal platform for Phase IV studies of post-licensing drug surveillance-programs.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Immunodeficiency Disease | – | –Patients with primary Immunodeficiency disease (PID) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice
Key inclusion criteria (1 listed)
- Primary Immunodeficiency Disease (PID)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Arthur Helbling, Prof. principal investigator
University Bern, Inselspital
Christoph Hess, Prof. principal investigator
University Basel, University Hospital
Ayse H Ozsahin, Prof. principal investigator
University Geneva, University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Disease, run by University of Zurich at 6 sites in Switzerland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. 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?
Results are not available in the source record.
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.
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 13 May 2016.