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

• ClinicalTrials.gov Identifier: NCT05928416
• Recruitment Status: Recruiting
• First Posted: July 3, 2023
• Last Update Posted: April 10, 2024
• Sponsor: ZIWIG
• Collaborator: Monitoring Force Group
• Information provided by (Responsible Party): ZIWIG

Tracking Information

• First Submitted Date: June 23, 2023
• First Posted Date: July 3, 2023
• Last Update Posted Date: April 10, 2024
• Actual Study Start Date: July 11, 2023
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 23, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
• Official Title: ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach

Brief 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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Saliva

• Sampling Method: Non-Probability Sample

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.

Condition

• Amyotrophic Lateral Sclerosis, Sporadic
• Amyotrophic Lateral Sclerosis

Intervention

• Diagnostic Test: Saliva sample

  During the inclusion visit :

  • a neurological examination is taken
  • a saliva sample is taken
• Diagnostic Test: Saliva sample

  During the inclusion visit :

  • a saliva sample is taken

Study Groups/Cohorts

• SLA group
  300 patients
  Intervention: Diagnostic Test: Saliva sample
• Control group
  300 patients
  Intervention: Diagnostic Test: Saliva sample

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 23, 2023): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2025
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Philippe Codron, Dr; +33 2 41 35 79 33; Philippe.codron@chu-angers.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05928416
• Other Study ID Numbers: 2023-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ZIWIG
• Original Responsible Party: Same as current
• Current Study Sponsor: ZIWIG
• Original Study Sponsor: Same as current
• Collaborators: Monitoring Force Group
• Investigators: Not Provided
• PRS Account: ZIWIG
• Verification Date: April 2024