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Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis (LARMOMIQUE)

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ClinicalTrials.gov Identifier: NCT04953286
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Study Description
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Brief Summary:
Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Measure of visual acuity Other: Interferometry Other: Samples of basal tears Other: Central corneal sensitivity Other: Slit lamp examination and undilated fundus Other: Conjunctival impression Other: Evaluation of the corneal innervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study
Actual Study Start Date : September 17, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Case group
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients with Amyotrophic Lateral Sclerosis
 Other: Measure of visual acuity
ETDRS and Parinaud scale

Other: Interferometry
Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus

Other: Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary

Other: Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)

Other: Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus

Other: Conjunctival impression
Conjunctival impression with anesthetic instillation

Other: Evaluation of the corneal innervation
Contact corneal confocal microscopy
Control group
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients without neurological disease
 Other: Measure of visual acuity
ETDRS and Parinaud scale

Other: Interferometry
Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus

Other: Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary

Other: Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)

Other: Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus

Other: Conjunctival impression
Conjunctival impression with anesthetic instillation

Other: Evaluation of the corneal innervation
Contact corneal confocal microscopy


Outcome Measures
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Primary Outcome Measures :
  1. Metabolome profile in tears for the diagnosis and prognosis of ALS. [ Time Frame: Baseline ]
    Once the composition in metabolites (i.e. tear metabolome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabolome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker

  2. Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS. [ Time Frame: Baseline ]
    Once the composition in metabolites in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.

  3. Lipidome profile in tears for the diagnosis and prognosis of ALS. [ Time Frame: Baseline ]
    Once the composition in lipids (i.e. tear lipidome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker

  4. Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS. [ Time Frame: Baseline ]
    Once the composition in lipids in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.


Secondary Outcome Measures :
  1. Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry [ Time Frame: Baseline ]
    By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).

  2. Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry [ Time Frame: Baseline ]
    By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Case group selection criteria :

Inclusion Criteria:

  • Patient with clinically defined or probable primary ALS according to Airlie House criteria(1)
  • Familial or sporadic form
  • ≥18 years of age
  • Patient affiliated with a social security plan
  • Informed consent signed by the patient

Exclusion Criteria:

  • Motor neuron disease mimicking ALS
  • Pregnant or breastfeeding woman
  • Treatment that may have a neuroprotective effect
  • Any eye drops or treatments that may interfere with tear production
  • Lens wearer
  • Eye surgery ≤3 months
  • Any ocular pathology other than ametropia, oculomotor disorder, amblyopia
  • Any general pathology other than ALS with ocular repercussions
  • Protective measure of guardianship or curators

Control group selection criteria:

Inclusion Criteria:

  • No diagnosed neurological pathology
  • ≥18 years of age
  • Patient affiliated with a social security plan
  • Informed consent signed by the participant

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Treatment likely to have a neuroprotective effect
  • Any eye drops or treatments that may interfere with tear production
  • Lens wearer
  • Eye surgery ≤3 months
  • Any ocular pathology except ametropia, oculomotor disorder, amblyopia
  • Any general pathology with ocular repercussions
  • Protective measure of guardianship or curator
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04953286


Contacts
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Contact: Raoul Kanav KHANNA, MD 02.47.47.37.24 ext +33 raoul.khanna@univ-tours.fr

Locations
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France
Ophthalmology Department, University Hospital of Tours, France Recruiting
Tours, France, 37000
Contact: Raoul K Khanna, MD    0247472767    raoul.khanna@univ-tours.fr   
Neurology Department, University Hospital of Tours, France Recruiting
Tours, France, 37044
Contact: Philippe CORCIA, MD-PhD         
Principal Investigator: Philippe CORCIA, MD-PhD         
Centre d'Investigation Clinique_CIC 1415 Not yet recruiting
Tours, France
Contact: Valérie GISSOT, MD         
Principal Investigator: Valérie GISSOT, MD         
Sponsors and Collaborators
University Hospital, Tours
More Information
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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT04953286    
Other Study ID Numbers: DR210051
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Amyotrophic Lateral Sclerosis
Biomarkers
Ocular Surface
Tear
Additional relevant MeSH terms:
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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