Active — Not RecruitingNot Applicable

ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach

France653 participantsStarted 2023-07-11

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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, Exclusion Criteria: * 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 ; * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the curve (AUC) of the Receiver Operating Curve (ROC)

Timeframe: Through the end of study inclusions, an average of 2 years

Trial details

NCT IDNCT05928416

SponsorZIWIG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-18

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis, Sporadic trials