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Clinical Trials/NCT03534752
NCT03534752
Completed
Not Applicable

Clinical Characteristics of Adult Patients With Inborn Errors of Metabolism in French-speaking Switzerland

University of Lausanne1 site in 1 country220 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inborn Errors of Metabolism
Sponsor
University of Lausanne
Enrollment
220
Locations
1
Primary Endpoint
Number of hospital admission
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This is a retrospective study aimed at establishing a database of the current health of adult patients with IEM in the French-speaking part of Switzerland. .

Detailed Description

Background Inborn errors of metabolism (IEMs) are a group of rare disorders caused by genetic mutations that affect enzymes of intermediary metabolism. Because adult with IEMs has become an emerging and challenging group in Switzerland, this study is intended to assess the actual situation of adult patients with IEM in the French-speaking part of Switzerland, namely their age, their sex, their diagnosis, age at disease onset and their clinical outcome including complications of the disease. All adult patients with a biochemical and/or genetic diagnosis of IEM followed at the adult metabolic clinic from the Lausanne University Hospital and Geneva University Hospital between 01.10.2013 to 31.12.2017 will be included in the study. In addition, investigators will also include the patients referred to the clinic for suspicion of IEM and determinate if the investigation confirmed an IEM disease. Electronic and paper patient charts will be reviewed for clinical features, biochemical investigations, molecular genetic testing, diagnostic imaging, treatment and long-term outcome. All data will be entered in an Excel database.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
April 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christel Tran

Principal Investigator

University of Lausanne

Eligibility Criteria

Inclusion Criteria

  • All IEM adult patients who were transitioned from the pediatric clinic to the adult metabolic clinic (the Centre for Molecular Disease in Lausanne and the Division of Endocrinology, Diabetology, Hypertension and Nutrition of the HUG) since its creation in 2013 and those who were referred to our clinic for suspicion of IEM and requiring further investigation.

Exclusion Criteria

  • Age \< 16 years . Any document attesting a refusal to participate will exclude the data entry of the concerned patient.

Outcomes

Primary Outcomes

Number of hospital admission

Time Frame: 4 years

Clinical outcome

Survival rate (%)

Time Frame: 4 years

Clinical Outcome

Specific treatment for Inborn Errors of Metabolism

Time Frame: 4 years

Treatment specific to each diseases including ammonia scavenger, enzyme replacement therapy, carnitine, ubiquinone, vitamins, specific diet, dialysis, specific metabolic formula

Gender (Male/female)

Time Frame: First visit

Demography outcome

Age at diagnosis (years/months)

Time Frame: First visit

Clinical outcome

Specific diagnosis of IEM listed by their frequency

Time Frame: First visit

Clinical outcome

Medical complications

Time Frame: 4 years

Clinical outcome including acute liver failure, nephropathy, metabolic acidosis, ophthalmologic anomalies, epilepsy, encephalopathy, myopathy, neuropathy, diabetes

Secondary Outcomes

  • Enzyme activity in leucocytes and/or fibroblasts(4 years)
  • Bone density test(4 years)
  • Biological biomarkers of specific diseases (lysosomal storage disorders and galactosemia)(4 years)
  • Clinical chemistry(4 years)
  • Abdominal Ultrasound results(4 years)
  • Magnetic resonance Imaging scan(4 years)
  • Hematology tests(4 years)
  • Molecular analysis results of candidate gene for Inborn Errors of metabolism(4 years)

Study Sites (1)

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