Title of study

    Biomarkers, environmental and lifestyle risk factors for amyotrophic lateral sclerosis

    Acronym for cohort

    ALSrisc

    Name of Principal Investigator - Title

    Dr

    Name of Principal Investigator - First name

    Fang

    Name of Principal Investigator - Last name

    Fang

    Address of institution -Institution

    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

    Address of institution - Street address

    Nobelsväg 12A

    Address of institution - City

    Stockholm

    Address of institution - Postcode

    171 77

    Country

    Sweden

    Website
    Contact email
    Funding source

    Swedish Research Council, Karolinska Institutet, Ulla-Carin Lindqvist Foundation

    Q1a. Please indicate below if your cohort includes or expects to include, incidence of the following conditions?

    Motor neurone diseases

    Q2a. In a single sentence what is the stated aim of the study? (Maximum 30 words)

    To identify potential biomarkers as well as genetic and non-genetic risk factors for ALS

    Q2b. What distinguishes this case-control study from other studies?

    Population-based design, multiple control groups, rich biosamples

    Q3a. i) Number of publications that involve use of your cohort to date

    0

    Q3a. ii) Please give up to three examples of studies to date (PI, Institution, Title of Study)

    Q3b. If data on research outputs are already available please paste the publication list/other data or provide a link to where these data are publicly available

    Q3c. If no research has been done as yet, please explain in a few sentences what information (i.e. research findings) you expect will be gained from the case-control study

    We aim to understand the impact of environmental and lifestyle risk factors on ALS risk, the interactions between these risk factors and ALS genes, as well as the impact of these risk fators on ALS prognosis.

    Q4a. Study criteria: what is the age range of participants at recruitment? Age in years From:

    20

    Q4a. Study criteria: what is the age range of participants at recruitment? To:

    until death

    Q4b. Study criteria: what are the inclusion criteria?

    Newly diagnosed ALS patients in the Stockholm area, during 2016-2018

    Q4c. Study criteria: what are the exclusion criteria?

    Non-Swedish speaking

    Q5a. What is the size of the cohort (i.e. how many participants have enrolled)?

    1-1,000

    Q5b. What is the expected number of control participants?

    200-500

    Q6a. Please describe what measures are used to characterise participants

    Questionnaire data, clinical medical records, and biosamples

    Q6b. Are there additional measures for participants with the clinical disorder?

    Q6c. Are there defined primary and secondary endpoints (e.g. defined health parameters)?

    Yes

    If YES please specify

    Death

    Q7. What is the study design?

    Prospective cohort| population-based case-control study

    Q8. Are your cases matched by

    Age| Sex|

    Q9a. Does your study includes a specialised subset of control participants?

    Yes

    Q9b. If your study includes a specialised subset of control participants please describe

    We include sibling and spouse controls

    Q10a. Is data collection for this study

    Data collection ongoing

    Q10b. If data collection is ongoing, are there plans to continue the cohort study beyond the current projected end date?

    Yes - intend to apply for funding

    Q11. Are data collected

    Only through the study| Through links to medical records| Through links to other records or registers(Swedish National Health Registers)

    Q12. Is there a system in place to enable re-contact with patients for future studies?

    No

    Q13a. Please give information on data stored in a database (1)

    Data summarised in database

    % Available

    100

    Q13a. Please give information on data stored in a database (2)

    % Available

    Q13a. Please give information on data stored in a database (3)

    % Available

    Q13a. Please give information on data stored in a database (4)

    % Available

    Q13a. Please give information on data stored in a database (5)

    Yes

    % Available

    100

    Please specify language used

    SAS/ACCESS

    % Available

    100

    Q13b. Please give information on how data is held as individual records

    % Available

    Q14a. Are data available to other groups?

    Yes

    Q14b. If data is available to other groups what is the access policy/mechanisms for access?

    Apply to PI or co-ordinator at resource| Access Committee mechanism| Local/ regional access| Local/ regional access| Local/ regional access| Access for pilot studies permitted| Access restricted to peer-reviewed work| Applicant needs to provide separate external ethics approval

    Q15. What data sharing policy is specified as a condition of use?

    No requirement to make data publicly available

    Q16a. Are tissues/samples/DNA available to other groups?

    Yes

    Q16b i) If yes, please describe below

    Living donors: blood| Living donors: blood derivatives| Living donors: DNA| Living donors: cerebro-spinal fluid| Living donors: other (saliva, fecal, hair, and nail samples)

    Q16b. ii) In what form are tissues/samples/DNA supplied?

    Primary samples: Supplied fresh| Secondary samples: plasma| Secondary samples: DNA

    Q16b iii) Is the access policy/mechanism for obtaining samples the same as that for obtaining data (Q14 above)?

    Yes

    Q17. Is information on biological characteristics available to other groups?

    No

Types: Case Control Studies
Member States: Sweden
Diseases: Motor neurone diseases
Years: 2016
Database Categories: N/A
Database Tags: N/A

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