Amyotrophic Lateral Sclerosis, SporadicRNALSNCT05928416
ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
An observational study of Amyotrophic Lateral Sclerosis, Sporadic and Amyotrophic Lateral Sclerosis, run by ZIWIG at 19 sites in France.
Trial summary
RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Sporadic, Amyotrophic Lateral Sclerosis
- What is being tested?
- Saliva sample
- How many people
- 653 participants
- Where
- 19 sitesFrance
- Study dates
- 11 Jul 2023to May 2026
- 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: The study population will be made up with amyotrophic lateral sclerosis (ALS) patients defined or probable according to El Escorial criteria ("ALS patients" group) and patients with no medical history or neurological symptoms (Control Group). The control group will be made up of people accompanying the patients (with or without ALS). The ALS patients in the study already benefit from routine medical care in ALS expert centers in France. . The patients concerned by the study are managed without modification of the care pathway, no modification of the therapeutic indications, no modification of the diagnostic examinations or follow-up necessary according to the context, which are carried out according to the recommendations of the HAS.
Who may be able to join
- Patient over 18 years of age,
- Patient from one of the 2 study populations:
- Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ;
- Control group
- Patient able to carry out a mouth rinse,
- Patient affiliated to the healthcare system,
- Patient has dated and signed the consent form,
Who cannot join
- Recent (<1 month) or ongoing bacterial or viral infection,
- Known active oral or digestive mycosis,
- Evolving, symptomatic or obvious oral pathology,
- Known pregnancy,
- Patient participating in another clinical research study,
- Patient deprived of liberty by administrative or judicial decision or under guardianship ;
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- Subject refusing to take a saliva sample;
- For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study;
- For control group: medical history of neurological disease (excluding migraine).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CHU Angers
Angers, 49933
CHU Bordeaux
Bordeaux, 33000
Hôpital Cavale Blanche
Brest, 29609
Hospices Civils de Lyon
Bron, Rhône, 69677
CHU Caen
Caen, 14000
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CHRU Lille
Lille, 59037
CHU Dupuytren
Limoges, 97042
Hôpital de La Timone
Marseille, 13005
CHU Montpellier
Montpellier, 34295
CHU Nice
Nice, 06100
Hôpital de la Pitié-Salpêtrière
Paris, 75013
CHU Rennes
Rennes, 35000
C.H.U. de Saint-Étienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055
CHU Nantes
Saint-Herblain, Loire-Atlantique, 44162
CHU de la Réunion
Saint-Pierre, 97448
CHU Strasbourg
Strasbourg, Alsace, 67098
CHU Toulouse
Toulouse, 31059
CHU Bretonneau
Tours, 37044
About this study
RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group).
Read more
The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS.
The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
- Being tested
- Saliva sample
- Keywords
- ALS, RNA, Saliva sample
- Medical subject headings
- Amyotrophic lateral sclerosis 1, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sampleDiagnostic test
During the inclusion visit :
- a neurological examination is taken
- a saliva sample is taken
Saliva sampleDiagnostic test
During the inclusion visit :
- a saliva sample is taken
| Study group | Role | What they receive |
|---|---|---|
| SLA group | 300 patients Receives: Diagnostic Test: Saliva sample | |
| Control group | 300 patients Receives: Diagnostic Test: Saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.
Measured: Through the end of study inclusions, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start11 Jul 2023
- Primary completion18 Nov 2025
- Study completionMay 2026 (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, SporadicStudies 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
- Prospective
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZIWIG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928416
- Sponsor's protocol ID
- 2023-01
- Acronym
- RNALS
- Status last verified
- Mar 2026
- First submitted
- 23 Jun 2023
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
- ClinicalTrials.gov ID
- NCT05928416
- Acronym / sponsor ID
- RNALS / 2023-01
- Keywords
- ALS, RNA, Saliva sample
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 653 participants (actual)
- Lead sponsor
- ZIWIGIndustry (pharma, biotech, devices)
- Collaborators
- Monitoring Force Group
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group).
The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS.
The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLA group | – | Diagnostic Test: Saliva sample300 patients |
| Control group | – | Diagnostic Test: Saliva sample300 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be made up with amyotrophic lateral sclerosis (ALS) patients defined or probable according to El Escorial criteria ("ALS patients" group) and patients with no medical history or neurological symptoms (Control Group). The control group will be made up of people accompanying the patients (with or without ALS). The ALS patients in the study already benefit from routine medical care in ALS expert centers in France. . The patients concerned by the study are managed without modification of the care pathway, no modification of the therapeutic indications, no modification of the diagnostic examinations or follow-up necessary according to the context, which are carried out according to the recommendations of the HAS.
Key inclusion criteria (7 listed)
- Patient over 18 years of age,
- Patient from one of the 2 study populations:
- Patient able to carry out a mouth rinse,
- Patient affiliated to the healthcare system,
- Patient has dated and signed the consent form,
Key exclusion criteria (9 listed)
- Recent (<1 month) or ongoing bacterial or viral infection,
- Known active oral or digestive mycosis,
- Evolving, symptomatic or obvious oral pathology,
- Known pregnancy,
- Patient participating in another clinical research study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva sampleDuring the inclusion visit : * a neurological examination is taken * a saliva sample is taken | Diagnostic test | Control group |
| Saliva sampleDuring the inclusion visit : * a saliva sample is taken | Diagnostic test | SLA group |
Primary outcome
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
Time frame: Through the end of study inclusions, an average of 2 years
Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.
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 27 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites 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, Sporadic and Amyotrophic Lateral Sclerosis, run by ZIWIG at 19 sites in France.
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 7 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of the Receiver Operating Curve (ROC) (time frame: Through the end of study inclusions, an average of 2 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 27 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.