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Rare Diseases clinical trials

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NCT ID: NCT04419363 Recruiting - Rare Diseases Clinical Trials

Burosumab in Children and Adolescents With X-linked Hypophosphatemia

Start date: March 18, 2018
Phase: Phase 4
Study type: Interventional

In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for <13- and >13-years old children affected with X-linked hypophosphatemia. 57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of >13-years old adolescents.

NCT ID: NCT04315727 Recruiting - Rare Diseases Clinical Trials

Identification of the Genetic Causes of Rare Diseases With Negative Exome Findings

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The GENOME + project will enroll patients (n = ca. 100) and their healthy parents with unclear molecular cause of the disease, suspected genetic cause of the disease and previous detailed molecular analysis like Whole Exome Sequencing (WES) did not lead to the identification of the disease causing mechanism. As well healthy parents of those affected for trio analysis (exception of one parent is not available for the study).

NCT ID: NCT04046796 Recruiting - Rare Diseases Clinical Trials

Genetic Causes of Discrepant Clinic in Monogenic Twins

DISCO-TWIN
Start date: December 1, 2019
Phase:
Study type: Observational

In the DISCO-TWIN study (prospective, open-label molecular-genetic study), twin pairs with one healthy and one affected twin with molecularly undiagnosed diseases will be analysed by means of omics technologies and/ or re-analysed using existing datasets. Phenotype and omics data will be shared within the University Hospital Tübingen and with external collaborators to improve the diagnostic rate of the subjects included in the study.

NCT ID: NCT04024774 Recruiting - Rare Diseases Clinical Trials

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

AnDDI-Solve-RD
Start date: November 14, 2019
Phase:
Study type: Observational

Most diagnostically unsolved rare disease have a genetic cause. These causes have not been found applying the current methodologies due to technical limitations (e.g. repeat expansions, changes in non-coding (intronic) regions) or, although methodically recorded, their pathophysiological significance but not classified as clinically relevant. A re- and meta-analysis of existing data sets with new algorithms and statistical models as well as the complementation with other omics technologies followed by functional follow-up studies in appropriate disease models (e.g. patient cell lines) allows to elucidate additional causes of diseases and improve the diagnosis of hereditary diseases. In addition to the direct examination of persons affected, the analysis of healthy family members, for example of parents, plays an important role in a so-called trio analysis, especially in the efficient filtering of the extensive data sets for newly created changes, so-called de novo- Variants (new mutations). In the context of the outlined analyzes, new disease genes can be found and validated. The gain of scientific knowledge due to a better understanding of basic cell biological mechanisms can contribute to the development of targeted therapeutic approaches. In this context, the Solve-RD project has been built and financed by the European Union with the ambitions to solve large numbers of rare disease, for which a molecular cause is not known yet by sophisticated combined omics approaches, and to improve diagnostics of rare disease patients. Solve-RD fully integrates with the newly formed European Reference Networks (ERNs) for rare diseases, and in particular the ERN-RND, -EURO-NMD, -ITHACA, and -GENTURIS. The AnDDI-Rares network is fully affiliated to the ERN ITHACA network and will actively contribute to the project, by the ambition of sharing knowledge about genes, genomic variants and phenotypes. The project will first reanalyse 18.000 negative exomes from the different ERNs performed in a diagnostic or research context (collection of biomaterial, clinical/phenotypic data plus next-generation sequencing has already been performed, and the patient/family has agreed previously in writing that their sample could be used for research related to their disease, with no study related presence required. The project will also propose new multi-omics analyses with new samples needed in 500 patients and their parents in total, justifying the AnDDI-Solve-RD project.

NCT ID: NCT03962452 Recruiting - Clinical trials for Genetic Predisposition

Mitochondrial Diseases - Long-read Genome and Transcriptome Sequencing in Cases Unresolved After Short-read Genomics

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The MiDiSeq project will enroll 20 unresolved index patients with suspected mitochondrial disease prioritized for genomic analysis.

NCT ID: NCT03854318 Recruiting - Rare Diseases Clinical Trials

Longitudinal Studies of Patient With FPDMM

Start date: March 28, 2019
Phase:
Study type: Observational

Background: Genes tell the body and its cells how to work. Familial platelet disease (FPD) or FPD with associated malignancies (FPDMM) is caused by a variant in the gene RUNX1. People with this disease may have problems with their blood and bleed for a long time when they are injured. Researchers want to learn more about RUNX1 variants and FPD. Objective: To learn more about FPD in people with RUNX1 variants to lead to better diagnosis, monitoring, and treatment. Eligibility: People any age with a suspected or confirmed RUNX1 variant People who have a family member with the variant Design: All participants will be screened with a phone call and a blood, saliva, or cheek cell sample. Participants with a suspected or confirmed variant will have 1 visit. It will last about 2 days. They will then have visits at least once a year. Visits will include: - Medical history and physical exam - Blood tests or saliva sample - Possible skin biopsy: A small piece of the participant s skin will be removed. - Bone marrow aspiration or biopsy: The participant s bone marrow will be removed by needle from a large bone such as the hip bone. - Possible apheresis: Blood will be removed from the body and certain blood cells will be taken out. The rest of the blood is returned to the body. Between visits, participants with a suspected or confirmed variant will keep a diary of disease symptoms and signs. Samples from all participants may be used for genetic testing

NCT ID: NCT03683966 Recruiting - Quality of Life Clinical Trials

MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study

MALTA-FABRY
Start date: October 27, 2017
Phase:
Study type: Observational

This study evaluates adherence to the oral chaperone therapy migalastat in patients with Fabry disease.

NCT ID: NCT03491280 Recruiting - Clinical trials for Genetic Predisposition

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

DiRiP-RD
Start date: May 1, 2018
Phase:
Study type: Observational

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.

NCT ID: NCT03424772 Recruiting - Clinical trials for Intellectual Disability

Whole Genome Sequencing in the Detection of Rare Undiagnosed Genetic Diseases in Children in China

Start date: January 18, 2018
Phase: N/A
Study type: Observational [Patient Registry]

To assess the indications and diagnostic efficiency of whole genome sequencing (WGS) in pediatric patients with unexplained intellectual disability/developmental delay, multiple congenital abnormalities and other rare and undiagnosed diseases

NCT ID: NCT03362164 Recruiting - Fabry Disease Clinical Trials

Evaluation of HEArt invoLvement in Patients With FABRY Disease

HEAL-FABRY
Start date: January 2001
Phase:
Study type: Observational

This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.