Diagnostic Research in Patients With Rare Diseases - Solving the Unsolved Rare Diseases

NCT ID: NCT03491280

Last Updated: 2022-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2025-04-30

Brief Summary

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The DiRiP study will enroll patients (n = 3500) with unclear rare diseases and suspected genetic reasons. In group 1 (n = 500) subjects are clinically characterized in the context of outpatient/ inpatient standard care at the UKT or cooperating location, NGS analyzes and other omics analyzes (transcriptomics, proteomics, metabolomics), functional cell biology studies will be performed. In group 2 diagnostics is already performed.

The DiRiP-study fully integrates with the newly formed European Reference Networks (ERNs) for rare diseases, and in particular the ERN-RND, -EURO-NMD, -ITHACA, and -GENTURIS.

Detailed Description

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In the DiRiP-RD study (monocentric, prospective, open-label diagnostic study), patients with genetically unexplained diseases will be analyzed or re-analyzed from existing datasets for further omics analysis. These are evaluated with regard to the following questions:

Primary:

* Verification of the genetic causes of unclear genetic diseases

Secondary:

* Improve number of diagnoses of unclear syndromes
* Further characterization of the identified gene defects
* Number of patients receiving appropriate therapy after successful diagnosis. In addition, patient phenotype and genotype data can be collected using a software tool for collecting and analyzing phenotypic information of patients with genetic disorders ( PhenoTips®) software to facilitate data exchange within the UKT, with external collaborators and data transfer to the Solve-RD project.

Conditions

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Rare Diseases Genetic Predisposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group 1

Subjects with unclear rare diseases, clinically characterized in the context of outpatient/ inpatient standard care at the University Hospital Tübingen (UKT) or cooperating location, genetic diagnostic (NGS diagnostic) must be performed.

NGS Diagnostic

Intervention Type GENETIC

Blood take for genetic diagnostic.

Group 2

Subjects with unclear rare diseases, genetic diagnostic (NGS diagnostic) is already performed.

NGS Diagnostic

Intervention Type GENETIC

Blood take for genetic diagnostic.

Interventions

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NGS Diagnostic

Blood take for genetic diagnostic.

Intervention Type GENETIC

Other Intervention Names

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Omics Technology

Eligibility Criteria

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Inclusion Criteria

* Unclear diagnosis
* Suspected genetic cause of the disease

Exclusion Criteria

* Missing informed consent of the patient/ legal guardian
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Ludger Schöls

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Holm Graessner, Dr.

Role: STUDY_CHAIR

Managing Director

Locations

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University Hospital

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Holm Graessner, Dr.

Role: CONTACT

+49 (0)7071/29-85944

Ludger Schöls, Prof. Dr.

Role: CONTACT

+49-(0)7071-2982057

Facility Contacts

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Ludger Schoels, Prof. Dr.

Role: primary

+49 (0)7071 ext. 2982057

Olaf Rieß, Prof. Dr.

Role: backup

+49 (0)7071 ext. 2972323

Other Identifiers

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DiRiP-RD

Identifier Type: -

Identifier Source: org_study_id

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