ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach (RNALS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05928416 |
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Recruitment Status :
Recruiting
First Posted : July 3, 2023
Last Update Posted : April 10, 2024
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis | Diagnostic Test: Saliva sample |
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach |
| Actual Study Start Date : | July 11, 2023 |
| Estimated Primary Completion Date : | July 2025 |
| Estimated Study Completion Date : | July 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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SLA group
300 patients
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Diagnostic Test: Saliva sample
During the inclusion visit :
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Control group
300 patients
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Diagnostic Test: Saliva sample
During the inclusion visit :
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- 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.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Patient over 18 years of age,
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05928416
| Contact: Philippe Codron, Dr | +33 2 41 35 79 33 | Philippe.codron@chu-angers.fr |
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| Responsible Party: | ZIWIG |
| ClinicalTrials.gov Identifier: | NCT05928416 |
| Other Study ID Numbers: |
2023-01 |
| First Posted: | July 3, 2023 Key Record Dates |
| Last Update Posted: | April 10, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ALS RNA Saliva sample |
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Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |