Amyotrophic Lateral Sclerosis (ALS)NCT03088839
Circulating Biomarker for Amyotrophic Lateral Sclerosis (ALS)
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Neuromed IRCCS at 1 site in Italy.
Trial summary
Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 60 individuals (30 subjects clinically diagnosed as ALS patients and 30 healthy controls) will be recruited at Centre for Rare Diseases, IRCCS Neuromed
Who may be able to join
- ALS patients admitted to Centre for Rare Diseases, IRCCS Neuromed,
- Patients diagnosed ALS within 6 months,
- Patients age between 20 years and 75 years old,
- Patients underwent to differential diagnosis using diagnostic tools (EMG, NCV, MRI) to exclude other diseases with similar signs and symptoms,
- Subjects able to communicate verbally or by using a non-verbal communication system.
Who cannot join
- Pregnant women,
- Subjects with malignant tumor,
- Subjects/Patients with others neurological or psychiatric disorders,
- Subjects/Patients with systemic diseases,
- Subjects/Patients with positive blood test for hepatitis B or C, or HIV,
- Patients included in other clinical trials,
- Subjects/Patients showing inability to understand the informed consent and the study's purpose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Case-Control Study to Identify Circulating miR-218 as a Possible Non-invasive Biomarker of Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any age but is more common in people aged over 40.
Although the molecular mechanism underlying the pathogenesis of ALS is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. Altered patterns of specific miRNAs expression have been described in several pathological conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in patients with ALS. Among others, miRNA-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate.
Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- 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 |
|---|---|---|
| 30 ALS patients | Not described | |
| 30 healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of circulating miR-218 as biomarker for ALS
Quantitative assessment of potential changes in the levels of miR-218 in the serum of ALS patients vs healthy controls
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start1 Dec 2017
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alba Di Pardo, Neuromed IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088839
- Sponsor's protocol ID
- ADP_01
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2017
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Case-Control Study to Identify Circulating miR-218 as a Possible Non-invasive Biomarker of Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03088839
- Acronym / sponsor ID
- ADP_01
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Mar 2017 (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.
Amyotrophic Lateral Sclerosis (ALS) is a rare disease with a worldwide incidence of 2-3 cases per 100,000 individuals/year and it is characterized by progressive neurodegeneration of motor neurons. When motor neurons degenerate the ability of the brain to initiate and control muscle movement is lost. ALS manifests in two forms: Familiar ALS (FALS) with inherited risk genotypes, accounts for only 10% of cases and sporadic ALS (SALS) without apparent heritability accounts for 90% of cases. ALS can occur in both female and male subjects at any age but is more common in people aged over 40.
Although the molecular mechanism underlying the pathogenesis of ALS is still under investigation, recent research has revealed that diseases affecting motor neurons may be associated to alterations of RNA metabolism and biogenesis of small non-coding micro RNAs (miRNAs). miRNAs are circulating molecules, whose expression profiles are widely described to have an important potential in monitoring the progression of a disease, to promote the development of more targeted therapies and/or to determine the effectiveness of treatments. Altered patterns of specific miRNAs expression have been described in several pathological conditions. Evidence shows a significant reduction in the levels of certain miRNAs also in patients with ALS. Among others, miRNA-218 has been described to play a critical role in the onset of motor neurons differentiation and in establishing cell identity and fate.
Changes in the levels of miRNA-218 in the serum of ALS patients may potentially provide useful tools to determine the possible association with this disease and to candidate it as indicator of disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 ALS patients | – | – |
| 30 healthy controls | – | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 individuals (30 subjects clinically diagnosed as ALS patients and 30 healthy controls) will be recruited at Centre for Rare Diseases, IRCCS Neuromed
Key inclusion criteria (5 listed)
- ALS patients admitted to Centre for Rare Diseases, IRCCS Neuromed,
- Patients diagnosed ALS within 6 months,
- Patients age between 20 years and 75 years old,
- Patients underwent to differential diagnosis using diagnostic tools (EMG, NCV, MRI) to exclude other diseases with similar signs and symptoms,
- Subjects able to communicate verbally or by using a non-verbal communication system.
Key exclusion criteria (7 listed)
- Pregnant women,
- Subjects with malignant tumor,
- Subjects/Patients with others neurological or psychiatric disorders,
- Subjects/Patients with systemic diseases,
- Subjects/Patients with positive blood test for hepatitis B or C, or HIV,
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
Identification of circulating miR-218 as biomarker for ALS
Time frame: 8 months
Quantitative assessment of potential changes in the levels of miR-218 in the serum of ALS patients vs healthy controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis (ALS), run by Neuromed IRCCS at 1 site in Italy.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alba Di Pardo (+39 0865 915212, dipardoa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of circulating miR-218 as biomarker for ALS (time frame: 8 months). 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 15 Mar 2023.