Clinical and Laboratory Online Patient- and Research Data... | NCT01150240

Studies
Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

NCT01150240

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

May 13, 2016Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Primary Immunodeficiency Disease

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Jun 23, 2010

First Submission Date that Met QC Criteria

Jun 23, 2010

First Posted Date

Jun 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2016

Last Update Posted Date

May 13, 2016Estimated

Name	Class
University of Basel	OTHER
University of Bern	OTHER
University Hospital, Geneva	OTHER
University of Lausanne

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary Immunodeficiency Disease		Patients with primary Immunodeficiency disease (PID)

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary Immunodeficiency Disease (PID)

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Primary Immunodeficiency Disease (PID), followed in a PID centre, primary care hospitals or private practice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arthur Helbling, Prof.	University Bern, Inselspital	Principal Investigator
Christoph Hess, Prof.	University Basel, University Hospital	Principal Investigator
Ayse H Ozsahin, Prof.	University Geneva, University Hospital	Principal Investigator
Francois Spertini, Prof.	University Lausanne, University Hospital	Principal Investigator
Hugo Ubieto, MD	Department of Child Development, Children's Hospital St. Gallen, Switzerland	Principal Investigator
Reinhard A Seger, Prof.	University Zürich, University Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel			Switzerland
University Hospital Bern

Condition Browse Module

MeSH Terms

ID	Term
D000081207	Primary Immunodeficiency Diseases

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided