ALSNCT07007390
Systems Biology of Amyotrophic Lateral Sclerosis (ALS)
An observational study of ALS and ALS (Amyotrophic Lateral Sclerosis), run by Viome.
Trial summary
The goal of this observational study is to identify molecular features in multiple clinical samples and/or the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ALS, ALS (Amyotrophic Lateral Sclerosis)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ALS cohort: Patients of Dr. Espíndola at UFSC Control cohort: Participants from the general population
Who may be able to join
- Patient of Dr. Espíndola at UFSC
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Momo Chief Science Officer, Head of Clinical Research, PhD contact
About this study
The goal of this observational study is to identify molecular features in multiple clinical samples and/or the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner.
- Conditions
- ALS, ALS (Amyotrophic Lateral Sclerosis)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS Cohort | Patients of Dr. Espíndola at UFSC that are diagnosed with ALS and meet the inclusion/exclusion criteria. | |
| Control Cohort | Those that meet the inclusion/exclusion criteria, do not have ALS, and generally are healthy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular features of biological samples that are predictive of ALS progression
Measured: We will collect samples and health data from each participant from the time of diagnosis to their death or study termination, whichever comes sooner. Specific time frame: We will collect outcome measures through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Feb 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by ViomeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Santa Catarina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007390
- Sponsor's protocol ID
- V234
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT07007390
- Acronym / sponsor ID
- V234
- Conditions
- ALS, ALS (Amyotrophic Lateral Sclerosis)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal de Santa Catarina
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to identify molecular features in multiple clinical samples and/or the patient environment that are associated with ALS. Participants will collect biological samples and answer questionnaires regarding their health at each appointment with their ALS practitioner.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS Cohort | – | –Patients of Dr. Espíndola at UFSC that are diagnosed with ALS and meet the inclusion/exclusion criteria. |
| Control Cohort | – | –Those that meet the inclusion/exclusion criteria, do not have ALS, and generally are healthy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ALS cohort: Patients of Dr. Espíndola at UFSC Control cohort: Participants from the general population
Key inclusion criteria (1 listed)
- Patient of Dr. Espíndola at UFSC
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular features of biological samples that are predictive of ALS progression
Time frame: We will collect samples and health data from each participant from the time of diagnosis to their death or study termination, whichever comes sooner. Specific time frame: We will collect outcome measures through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Momo Chief Science Officer, Head of Clinical Research, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and ALS (Amyotrophic Lateral Sclerosis), run by Viome.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Clinical Research Coordinator, BS (425-368-5248, studies@viome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular features of biological samples that are predictive of ALS progression (time frame: We will collect samples and health data from each participant from the time of diagnosis to their death or study termination, whichever comes sooner. Specific time frame: We will collect outcome measures through study completion, an average of 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.