ClinicalTrials.gg
CompletedNCT01699451Updated Feb 15, 2022

DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida

An observational study in Amyotrophic Lateral Sclerosis (ALS), sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study summary

This study is intended to obtain clinical information and establish a repository of DNA, RNA, peripheral blood monocyte, lymphocyte and skin tissue samples from people with ALS and related neurodegenerative motor neuron diseases, people with a family history of these conditions, and healthy people with no family history of these disorders. The samples will be used in future research to learn about how these disorders affect people, what causes these conditions, and how the investigators can tell when someone has this kind of disease. Future research may also include the generation of stem cells from stored blood cell and skin cell samples. Participants will not be paid for taking part in this study.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis (ALS)
03

In context

Amyotrophic Lateral Sclerosis

1,000 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 284 are open to participants now.

This study's enrollment of 33 is below the median of 103 across 272 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Eligible patients will be female or male, > or = 18 years of age. ALS and control subjects will meet eligibility criteria. Control subjects will be similar in age to ALS patients. No special classes of subjects are specifically sought or excluded from the protocol.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ALS Patient

    1. Clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS according to modified EL Escorial criteria, suspected ALS according to original El Escorial criteria, or diagnosis of a neurodegenerative disorder with evidence of ALS plus extramotor features
    2. > or = 18 years of age and willing to provide consent, or assent, if unable to consent
  • Subject with family history of ALS or other relevant neurodegenerative disease

    1. No personal history of ALS, ALS-FTD or other motor neuron disease
    2. Family history of ALS, ALS-FTD in a first, second or third degree blood relative
    3. > or = 18 years of age and willing to provide consent
  • Control

    1. No personal or family history (first or second degree blood relative) of ALS, dementia, Parkinson disease or other relevant neurodegenerative disorder
    2. > or = 18 years of age and willing to provide consent

Exclusion criteria

Exclusion Criteria:

  • ALS Subject and subject with family history of ALS/ALS-FTD or other neurodegenerative motor neuron disorder but no personal history of such conditions

    1. History of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be contributed to by an acquired condition
    2. Limited mental capacity rendering the subject unable to comply with skin punch biopsy or standard phlebotomy procedures
    3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
  • Healthy Control Subject

    1. Personal or family history of dementia or other neurodegenerative disease (Parkinson disease, Alzheimer disease, etc.)
    2. Limited mental capacity rendering the subject unable to provide written informed consent or comply with standard phlebotomy procedures
    3. For collection of skin punch biopsy, an increased risk of bleeding complications or allergy to local anesthetic administered at the time of skin biopsy
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
33 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Repository sample collection

    Time frame: once

07

Study locations

1 site
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01699451
Lead sponsor
Mayo Clinic
Responsible party
Bjorn E. Oskarsson (PI, Mayo Clinic) — Principal investigator
First posted
Oct 3, 2012
Start date
Sep 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 15, 2022

Study contacts

Bjorn Oskarsson, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion