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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of visual acuity
Interferometry
Samples of basal tears
Central corneal sensitivity
Slit lamp examination and undilated fundus
Conjunctival impression
Evaluation of the corneal innervation
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Biomarkers, Ocular Surface, Tear

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 and ≤75 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 and ≤75 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

Sites / Locations

  • Ophthalmology Department, University Hospital of Tours, FranceRecruiting
  • Neurology Department, University Hospital of Tours, FranceRecruiting
  • Centre d'Investigation Clinique_CIC 1415

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Case group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Metabolome profile in tears for the diagnosis and prognosis of ALS.
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
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
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.
Lipidome profile in tears for the diagnosis and prognosis of ALS.
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
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
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

Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
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).
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
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).

Full Information

First Posted
May 17, 2021
Last Updated
January 24, 2023
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT04953286
Brief Title
Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis
Acronym
LARMOMIQUE
Official Title
Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Biomarkers, Ocular Surface, Tear

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Other
Arm Description
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
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Measure of visual acuity
Intervention Description
ETDRS and Parinaud scale
Intervention Type
Other
Intervention Name(s)
Interferometry
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Samples of basal tears
Intervention Description
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Intervention Type
Other
Intervention Name(s)
Central corneal sensitivity
Intervention Description
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Intervention Type
Other
Intervention Name(s)
Slit lamp examination and undilated fundus
Intervention Description
Slit lamp examination and undilated fundus
Intervention Type
Other
Intervention Name(s)
Conjunctival impression
Intervention Description
Conjunctival impression with anesthetic instillation
Intervention Type
Other
Intervention Name(s)
Evaluation of the corneal innervation
Intervention Description
Contact corneal confocal microscopy
Primary Outcome Measure Information:
Title
Metabolome profile in tears for the diagnosis and prognosis of ALS.
Description
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
Time Frame
Baseline
Title
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Description
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.
Time Frame
Baseline
Title
Lipidome profile in tears for the diagnosis and prognosis of ALS.
Description
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
Time Frame
Baseline
Title
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Description
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).
Time Frame
Baseline
Title
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raoul Kanav KHANNA, MD
Phone
02.47.47.37.24
Ext
+33
Email
raoul.khanna@univ-tours.fr
Facility Information:
Facility Name
Ophthalmology Department, University Hospital of Tours, France
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul K Khanna, MD
Phone
0247472767
Email
raoul.khanna@univ-tours.fr
Facility Name
Neurology Department, University Hospital of Tours, France
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe CORCIA, MD-PhD
First Name & Middle Initial & Last Name & Degree
Philippe CORCIA, MD-PhD
Facility Name
Centre d'Investigation Clinique_CIC 1415
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie GISSOT, MD
First Name & Middle Initial & Last Name & Degree
Valérie GISSOT, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis

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