Genetic Study of Amyotrophic Lateral Sclerosis in Norway

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Observation

• Registration Number: NCT05119387
• Lead Sponsor: Sykehuset Telemark

Brief Summary

The purpose of this study is to explore the genetic causes relevant for ALS development in Norway.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn. Blood samples, questionnaires, clinical information and signed consent is send to Department of Medical Genetics, Telemark Hospital Trust were the genetic analysis is performed successively throughout the recruitment period. Patients can choose to have their genetic results returned in a diagnostic setting.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2030-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Probable or definite ALS
• Eligible to consent

Exclusion Criteria

• not competent to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals diagnosed with ALS	Observation	Individuals diagnosed with ALS that are being followed through the Norwegian health-care system. ALS patients ( probable or definite per El-Escorial criteria)

Primary Outcome Measures

Name	Time	Method
Gene frequency	2020-2030	Number of patients with disease causing mutations in high penetrant ALS genes
New ALS genes	2024-2030	Identify new ALS genes in the Norwegian ALS population
Genetic risk factors	2022-2030	Identify genetic risk factors for ALS in Norway.

Trial Locations

Locations (17)

Haukeland University Hospital, Department of Neurology; 🇳🇴 Bergen, Norway

Nordland Hospital Trust, Department of Neurology; 🇳🇴 Bodø, Norway

Vestre Viken Hospital Trust, Department of Neurology; 🇳🇴 Drammen, Norway

Førde Hospital Trust, Department of Neurology; 🇳🇴 Førde, Norway

Østfold Hospital Trust, Department of Neurology; 🇳🇴 Grålum, Norway

Fonna Hospital Trust, Department of Neurology; 🇳🇴 Haugesund, Norway

Sørlandet Hospital Trust, Department of Neurology; 🇳🇴 Kristiansand, Norway

Innlandet Hospital Trust, Department of Neurology; 🇳🇴 Lillehammer, Norway

Akershus University Hospital, Department of Neurology; 🇳🇴 Lørenskog, Norway

Møre and Romsdal Hospital Trust, Department of Neurology; 🇳🇴 Molde, Norway

Nord-Trøndelag Hospital Trust, Department of Neurology; 🇳🇴 Namsos, Norway

Oslo University Hospital, Department of Neurology; 🇳🇴 Oslo, Norway

Telemark Hospital, Department of Neurology; 🇳🇴 Skien, Norway

Stavanger University Hospital, Department of Neurology; 🇳🇴 Stavanger, Norway

University hospital of North Norway, Department of Neurology; 🇳🇴 Tromsø, Norway

St. Olavs Hospital, Department of Neurology; 🇳🇴 Trondheim, Norway

Vestfold Hospital Trust, Department of Neurology; 🇳🇴 Tønsberg, Norway