Clinical trial NCT05119387: Genetic Study of Amyotrophic Lateral Sclerosis in Norway
Official title: Genetisk Studie av Amyotrofisk Lateral Sklerose (ALS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Genetics
Amyotrophic Lateral Sclerosis
Neurology
Clinical genetics
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: ALS Norge
name: Helse Sor-Ost
First posted: 2021-11-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with ALS that are being followed through the Norwegian health-care system.

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informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn.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.

Eligibility criteria: Inclusion Criteria:

* Probable or definite ALS
* Eligible to consent

Exclusion Criteria:

- not competent to give consent

Primary outcomes:
measure: Gene frequency
timeFrame: 2020-2030
measure: New ALS genes
timeFrame: 2024-2030
measure: Genetic risk factors
timeFrame: 2022-2030
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital, Department of Neurology
city: Bodø
country: Norway
facility: Nordland Hospital Trust, Department of Neurology
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust, Department of Neurology
city: Førde
country: Norway
facility: Førde Hospital Trust, Department of Neurology
city: Grålum
country: Norway
facility: Østfold Hospital Trust, Department of Neurology
city: Haugesund
country: Norway
facility: Fonna Hospital Trust, Department of Neurology
city: Kristiansand
country: Norway
facility: Sørlandet Hospital Trust, Department of Neurology
city: Lillehammer
country: Norway
facility: Innlandet Hospital Trust, Department of Neurology
city: Lørenskog
country: Norway
facility: Akershus University Hospital, Department of Neurology
city: Molde
country: Norway
facility: Møre and Romsdal Hospital Trust, Department of Neurology
city: Namsos
country: Norway
facility: Nord-Trøndelag Hospital Trust, Department of Neurology
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Neurology
city: Skien
country: Norway
facility: Telemark Hospital, Department of Neurology
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Neurology
city: Tromsø
country: Norway
facility: University hospital of North Norway, Department of Neurology
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Department of Neurology
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust, Department of Neurology
Study officials:
affiliation: Telemark Hospital Trust, Norway
name: Helle Høyer
role: PRINCIPAL_INVESTIGATOR
References: