Amyotrophic Lateral SclerosisSalivALSNCT04233099
Salivary Biomarker Discovery by Raman Spectroscopy in ALS (SalivALS)
An observational study of Amyotrophic Lateral Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
Trial summary
BACKGROUND/RATIONALE: The paucity of biomarkers for the diagnosis and monitoring of patients affected by Amyotrophic Lateral Sclerosis (ALS) is one of the greatest concerns in ALS clinics and research. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Raman analysis of saliva with data collection and analysis
- Type of treatment
- Surgery or procedure
- How many people
- 126 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be recruited from the primary care clinic patients under treatment at Fondazione Don Carlo Gnocchi - IRCCS Santa Maria Nascente and at Istituto Auxologico Italiano in Milan (Italy)
Who may be able to join
- Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria and classification based on the main genetic mutations for the ALS group
- Diagnosis of Alzheimer's disease according to the ATN criteria for the Alzheimer's group
- Diagnosis of Parkinson's disease according to the Unified Parkinson's Disease Rating Scale and with Hoehn and Yahr scores for the Parkinson's group
- Male
- Age between 50 and 70 years
Who cannot join
- Oncologic Diseases
- Immune and hematological diseases
- Bacterial or fungal infections in progress (e.g. oral candidiasis)
- Female
- Age less than 50 years or above 70 years
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Milan, 20148
Istituto Auxologico Italiano
Milan, 20149
About this study
Official title: Salivary Raman Fingerprint as Biomarker for the Diagnosis of Amyotrophic Lateral Sclerosis
BACKGROUND/RATIONALE: The paucity of biomarkers for the diagnosis and monitoring of patients affected by Amyotrophic Lateral Sclerosis (ALS) is one of the greatest concerns in ALS clinics and research. Phenotypic signs, electrophysiological test and clinical scales are currently used for ALS diagnosis and follow up before and after treatments. Nowadays, the diagnosis and differential diagnosis used to discriminate ALS from other comparable neurodegenerative diseases, are time-consuming and complex processes that reduce the time for a prompt intervention. Thus, the scientific community is asked to strive for new, measurable, fast and objective biomarkers for the diagnosis and stratification of patients. Saliva is a complex biofluid composed of bioactive molecules that can be collected by means of a non-invasive procedure. The possibility to simultaneously monitor all the variations in the endocrine, electrolytic and metabolic messengers in saliva has recently suggested its use for the diagnosis of complex diseases, like neurodegenerative diseases, but only limited information are available on the potential of saliva as alternative carrier of ALS biomarkers.
OBJECTIVES: The aim of the present project is to optimize an innovative, non-invasive and fast procedure for the ALS onset and for the stratification of ALS patients, taking advantage of the sensitivity of Raman Spectroscopy (RS) and of accessible saliva. Fondazione Don Gnocchi (FDG) preliminary results on a small cohort of subjects demonstrated the feasibility of the methodology and the ability of LABION protocol to obtain a reproducible Raman fingerprint of saliva that can be used for the discrimination of healthy subjects, ALS patients and subjects affected by other types of neurological diseases.
Read more
METHODS: Starting from FDG preliminary results, the biochemical composition of saliva in patients with diagnosed ALS will be evaluated and statistically compared with the one obtained from age and sex-matched healthy subjects and from patients affected by other neurological diseases (Parkinson's and Alzheimer's diseases). Moreover, an intra-group ALS clustering will be analysed in order to verify a different Raman fingerprint obtained from ALS patients with a bulbar or spinal onset. The collected Raman data will be processed using a multivariate analysis approach through Principal Component Analysis - Linear Discriminant Analysis (PCA-LDA). The classification model will be created using cross-validation and subset validation. Thanks to RS, the overall composition of saliva will be established with minimal sample preparation, providing comprehensive biochemical fingerprint of the sample. In parallel, routine salivary parameters will be measured including viscosity, pH, total protein and carbohydrates concentration, amylase and pepsin, cortisol and Chromogranin A.
EXPECTED RESULTS: By the end of this study, the investigators expected to verify the possibility to use the Raman salivary pattern as new promising biomarker for ALS diagnosis and progression to be related with clinical scales for the personalized and fine tuning of the therapeutic approach. The intent of this project is to create a classification model able to:
- Determine the ALS onset
- Discriminate the signal obtained from ALS patients from the one collected from other neurodegenerative diseases
- Stratify ALS patients into bulbar and spinal onset
- Correlate the Raman data with clinical and paraclinical scales used nowadays for ALS diagnosis and monitoring
Read the detailed description
SAMPLE COLLECTION: Saliva collection from all the selected subjects will be performed following the Salivette (SARSTEDT) manufacturer's instructions. To limit variability in salivary content not related to ALS, saliva will be obtained from all subjects at a fixed time, after an appropriate lag time from feeding and teeth brushing. Pre-analytical parameters (i.e. storage temperature and time between collection and processing), dietary and smoking habit will be properly recorded. Briefly, the swab will be removed, placed in the mouth and chewed for 60 seconds to stimulate salivation. Then the swab will be centrifuged for 2 minutes at 1,000 g to remove cells fragments and food debris. Collected samples will be stored at -80° C.
SAMPLE PROCESSING: Before the Raman acquisition, saliva samples will be filtered with different cut-off ranges (3, 10 and 30 kDa), collecting and analysing by RS the eluted sample and discarding the concentrated counterpart. For the Raman analysis, a drop of each sample will be casted on an aluminium foil in order to achieve the Surface Enhanced Raman Scattering (SERS).
DATA COLLECTION: Raman and SERS spectra will be acquired using an Aramis Raman microscope (Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm with laser power ranging from 25-100% (Max power 512 mW). Acquisition time between 10-30 seconds will be used. The instrument will be calibrated before each analysis using the reference band of silicon at 520.7 cm-1. Raman spectra will be collected from 15 points following a line-map from the edge to the centre of the drop. Spectra will be acquired in the region between 400 and 1800 cm-1 using a 50x objective (Olympus, Japan). Spectra resolution is about 1.2 cm-1. The software package LabSpec 6 (Horiba Jobin-Yvon, France) will be used for map design and the acquisition of spectra.
DATA PROCESSING: All the acquired spectra will be fit with a fifth-degree polynomial baseline and normalized by unit vector using the dedicated software LabSpec 6. The contribution of the substrate will be removed from each spectra. The statistical analysis to validate the method, will be performed using a multivariate analysis approach. Principal Component analysis (PCA) will be performed in order to reduce data dimensions and to evidence major trends. The first 20 resultant Principal Components (PCs) will be used in a classification model, Linear Discriminant Analysis (LDA), to discriminate the data maximizing the variance between the selected groups. The smallest number of PCs will be selected to prevent data overfitting. Leave-one-out cross-validation and confusion matrix test will be used to evaluate the method sensitivity, precision and accuracy of the LDA model. Mann-Whitney will be performed on PCs scores to verify the differences statistically relevant between the analysed groups. Correlation and partial correlation analysis will be performed using the Spearman's test, assuming as valid correlation only the coefficients with a p-value lower than 0.05. The statistical analysis will be performed using Origin2018 (OriginLab, USA).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Raman analysis of saliva with data collection and analysis
- Keywords
- Raman Spectroscopy, Amyotrophic Lateral Sclerosis, Biomarker, Diagnosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman analysis of saliva with data collection and analysisProcedure or surgery
Saliva collection and processing to all the enrolled subjects and consecutive Raman analysis of the biological fluid. Statistical processing of the collected data.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | 20 Healthy subjects in a good state of health comparable by age and sex with the other selected groups Receives: Procedure: Raman analysis of saliva with data collection and analysis | |
| Amyotrophic Lateral Sclerosis with Bulbar onset | 20 subjects affected by Amyotrophic Lateral Sclerosis with Bulbar onset, comparable by age and sex with the other selected groups Receives: Procedure: Raman analysis of saliva with data collection and analysis | |
| Amyotrophic Lateral Sclerosis with Spinal onset | 20 subjects affected by Amyotrophic Lateral Sclerosis with Spinal onset, comparable by age and sex with the other selected groups Receives: Procedure: Raman analysis of saliva with data collection and analysis | |
| Parkinson's Disease | 20 subjects affected by Parkinson's Disease comparable by age and sex with the other selected groups Receives: Procedure: Raman analysis of saliva with data collection and analysis | |
| Alzheimer's Disease | 20 subjects affected by Alzheimer's Disease comparable by age and sex with the other selected groups Receives: Procedure: Raman analysis of saliva with data collection and analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a new ALS biomarker in the saliva of people affected by Amyotrophic Lateral Sclerosis (ALS) using Raman Spectroscopy
Raman spectroscopy will be used to identify a new salivary biomarker for the fast discrimination between healthy subjects and patients affected by ALS. Saliva samples will be collected and processed without any labeling procedure, investigating the overall salivary biochemistry of the two investigated groups. Using multivariate analysis on the collected data we will be able to create a classification model that can discriminate ALS signature from healthy subjects.
Measured: One day
Evaluation of the spectral differences in the saliva of patients with different neurological diseases
The Raman data collected from ALS patients will be compared with the one obtained from patients affected by Alzheimer's and Parkinson's disease, validating our methodology as differential diagnostic tool for the discrimination of ALS from other neurological diseases
Measured: One day
Evaluation of the spectral differences in the saliva of patients with bulbar or spinal ALS onset
The intra-group analysis of recruited spinal and bulbar ALS patients will reveal the Raman fingerprint associated to the specific pathological subtype. This result will be important for the stratification of ALS patients after the ALS diagnosis.
Measured: One Day
Correlation of Raman data with clinical and paraclinical data
Raman data related to the ALS group will be correlated with clinical and paraclinical data, validating in this way our methodology. Collected data will be correlated primarily with factors that can alterate the biochemical composition of saliva including age, smoking habit, time before the last meal, time before teeth brushing, percutaneous endoscopic gastrostomy, mechanical ventilation and others. Consequently the same data will be analysed finding correlations with ALS-FRS (Amyotrophic Lateral Sclerosis - Functional Rating Scale), WHO-QOL (World of Health Organization - Quality of Life), blood analysis outcome, time from the diagnosis and other
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jul 2019
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Responsible party
- Sponsor
- Investigators
- Marzia Bedoni, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ONLUS, Laboratory of Nanomedicine and Clinical Biophotonics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233099
- Sponsor's protocol ID
- FDG_SalivaALS_02
- Acronym
- SalivALS
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2020
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Devitt G, Howard K, Mudher A, Mahajan S. Raman Spectroscopy: An Emerging Tool in Neurodegenerative Disease Research and Diagnosis. ACS Chem Neurosci. 2018 Mar 21;9(3):404-420. doi: 10.1021/acschemneuro.7b00413. Epub 2018 Feb 6.
PubMed 29308873van Es MA, Hardiman O, Chio A, Al-Chalabi A, Pasterkamp RJ, Veldink JH, van den Berg LH. Amyotrophic lateral sclerosis. Lancet. 2017 Nov 4;390(10107):2084-2098. doi: 10.1016/S0140-6736(17)31287-4. Epub 2017 May 25.
PubMed 28552366
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Raman Fingerprint as Biomarker for the Diagnosis of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT04233099
- Acronym / sponsor ID
- SalivALS / FDG_SalivaALS_02
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Raman Spectroscopy, Amyotrophic Lateral Sclerosis, Biomarker, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND/RATIONALE: The paucity of biomarkers for the diagnosis and monitoring of patients affected by Amyotrophic Lateral Sclerosis (ALS) is one of the greatest concerns in ALS clinics and research. Phenotypic signs, electrophysiological test and clinical scales are currently used for ALS diagnosis and follow up before and after treatments. Nowadays, the diagnosis and differential diagnosis used to discriminate ALS from other comparable neurodegenerative diseases, are time-consuming and complex processes that reduce the time for a prompt intervention. Thus, the scientific community is asked to strive for new, measurable, fast and objective biomarkers for the diagnosis and stratification of patients. Saliva is a complex biofluid composed of bioactive molecules that can be collected by means of a non-invasive procedure. The possibility to simultaneously monitor all the variations in the endocrine, electrolytic and metabolic messengers in saliva has recently suggested its use for the diagnosis of complex diseases, like neurodegenerative diseases, but only limited information are available on the potential of saliva as alternative carrier of ALS biomarkers.
OBJECTIVES: The aim of the present project is to optimize an innovative, non-invasive and fast procedure for the ALS onset and for the stratification of ALS patients, taking advantage of the sensitivity of Raman Spectroscopy (RS) and of accessible saliva. Fondazione Don Gnocchi (FDG) preliminary results on a small cohort of subjects demonstrated the feasibility of the methodology and the ability of LABION protocol to obtain a reproducible Raman fingerprint of saliva that can be used for the discrimination of healthy subjects, ALS patients and subjects affected by other types of neurological diseases.
METHODS: Starting from FDG preliminary results, the biochemical composition of saliva in patients with diagnosed ALS will be evaluated and statistically compared with the one obtained from age and sex-matched healthy subjects and from patients affected by other neurological diseases (Parkinson's and Alzheimer's diseases). Moreover, an intra-group ALS clustering will be analysed in order to verify a different Raman fingerprint obtained from ALS patients with a bulbar or spinal onset. The collected Raman data will be processed using a multivariate analysis approach through Principal Component Analysis - Linear Discriminant Analysis (PCA-LDA). The classification model will be created using cross-validation and subset validation. Thanks to RS, the overall composition of saliva will be established with minimal sample preparation, providing comprehensive biochemical fingerprint of the sample. In parallel, routine salivary parameters will be measured including viscosity, pH, total protein and carbohydrates concentration, amylase and pepsin, cortisol and Chromogranin A.
EXPECTED RESULTS: By the end of this study, the investigators expected to verify the possibility to use the Raman salivary pattern as new promising biomarker for ALS diagnosis and progression to be related with clinical scales for the personalized and fine tuning of the therapeutic approach. The intent of this project is to create a classification model able to:
- Determine the ALS onset
- Discriminate the signal obtained from ALS patients from the one collected from other neurodegenerative diseases
- Stratify ALS patients into bulbar and spinal onset
- Correlate the Raman data with clinical and paraclinical scales used nowadays for ALS diagnosis and monitoring
Detailed description
SAMPLE COLLECTION: Saliva collection from all the selected subjects will be performed following the Salivette (SARSTEDT) manufacturer's instructions. To limit variability in salivary content not related to ALS, saliva will be obtained from all subjects at a fixed time, after an appropriate lag time from feeding and teeth brushing. Pre-analytical parameters (i.e. storage temperature and time between collection and processing), dietary and smoking habit will be properly recorded. Briefly, the swab will be removed, placed in the mouth and chewed for 60 seconds to stimulate salivation. Then the swab will be centrifuged for 2 minutes at 1,000 g to remove cells fragments and food debris. Collected samples will be stored at -80° C.
SAMPLE PROCESSING: Before the Raman acquisition, saliva samples will be filtered with different cut-off ranges (3, 10 and 30 kDa), collecting and analysing by RS the eluted sample and discarding the concentrated counterpart. For the Raman analysis, a drop of each sample will be casted on an aluminium foil in order to achieve the Surface Enhanced Raman Scattering (SERS).
DATA COLLECTION: Raman and SERS spectra will be acquired using an Aramis Raman microscope (Horiba Jobin-Yvon, France) equipped with a laser light source operating at 785 nm with laser power ranging from 25-100% (Max power 512 mW). Acquisition time between 10-30 seconds will be used. The instrument will be calibrated before each analysis using the reference band of silicon at 520.7 cm-1. Raman spectra will be collected from 15 points following a line-map from the edge to the centre of the drop. Spectra will be acquired in the region between 400 and 1800 cm-1 using a 50x objective (Olympus, Japan). Spectra resolution is about 1.2 cm-1. The software package LabSpec 6 (Horiba Jobin-Yvon, France) will be used for map design and the acquisition of spectra.
DATA PROCESSING: All the acquired spectra will be fit with a fifth-degree polynomial baseline and normalized by unit vector using the dedicated software LabSpec 6. The contribution of the substrate will be removed from each spectra. The statistical analysis to validate the method, will be performed using a multivariate analysis approach. Principal Component analysis (PCA) will be performed in order to reduce data dimensions and to evidence major trends. The first 20 resultant Principal Components (PCs) will be used in a classification model, Linear Discriminant Analysis (LDA), to discriminate the data maximizing the variance between the selected groups. The smallest number of PCs will be selected to prevent data overfitting. Leave-one-out cross-validation and confusion matrix test will be used to evaluate the method sensitivity, precision and accuracy of the LDA model. Mann-Whitney will be performed on PCs scores to verify the differences statistically relevant between the analysed groups. Correlation and partial correlation analysis will be performed using the Spearman's test, assuming as valid correlation only the coefficients with a p-value lower than 0.05. The statistical analysis will be performed using Origin2018 (OriginLab, USA).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Procedure: Raman analysis of saliva with data collection and analysis20 Healthy subjects in a good state of health comparable by age and sex with the other selected groups |
| Amyotrophic Lateral Sclerosis with Bulbar onset | – | Procedure: Raman analysis of saliva with data collection and analysis20 subjects affected by Amyotrophic Lateral Sclerosis with Bulbar onset, comparable by age and sex with the other selected groups |
| Amyotrophic Lateral Sclerosis with Spinal onset | – | Procedure: Raman analysis of saliva with data collection and analysis20 subjects affected by Amyotrophic Lateral Sclerosis with Spinal onset, comparable by age and sex with the other selected groups |
| Parkinson's Disease | – | Procedure: Raman analysis of saliva with data collection and analysis20 subjects affected by Parkinson's Disease comparable by age and sex with the other selected groups |
| Alzheimer's Disease | – | Procedure: Raman analysis of saliva with data collection and analysis20 subjects affected by Alzheimer's Disease comparable by age and sex with the other selected groups |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be recruited from the primary care clinic patients under treatment at Fondazione Don Carlo Gnocchi - IRCCS Santa Maria Nascente and at Istituto Auxologico Italiano in Milan (Italy)
Key inclusion criteria (5 listed)
- Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria and classification based on the main genetic mutations for the ALS group
- Diagnosis of Alzheimer's disease according to the ATN criteria for the Alzheimer's group
- Diagnosis of Parkinson's disease according to the Unified Parkinson's Disease Rating Scale and with Hoehn and Yahr scores for the Parkinson's group
- Male
- Age between 50 and 70 years
Key exclusion criteria (5 listed)
- Oncologic Diseases
- Immune and hematological diseases
- Bacterial or fungal infections in progress (e.g. oral candidiasis)
- Female
- Age less than 50 years or above 70 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman analysis of saliva with data collection and analysisSaliva collection and processing to all the enrolled subjects and consecutive Raman analysis of the biological fluid. Statistical processing of the collected data. | Procedure or surgery | Alzheimer's Disease, Amyotrophic Lateral Sclerosis with Bulbar onset, Amyotrophic Lateral Sclerosis with Spinal onset, Healthy Subjects, Parkinson's Disease |
Primary outcome
Identification of a new ALS biomarker in the saliva of people affected by Amyotrophic Lateral Sclerosis (ALS) using Raman Spectroscopy
Time frame: One day
Raman spectroscopy will be used to identify a new salivary biomarker for the fast discrimination between healthy subjects and patients affected by ALS. Saliva samples will be collected and processed without any labeling procedure, investigating the overall salivary biochemistry of the two investigated groups. Using multivariate analysis on the collected data we will be able to create a classification model that can discriminate ALS signature from healthy subjects.
Evaluation of the spectral differences in the saliva of patients with different neurological diseases
Time frame: One day
The Raman data collected from ALS patients will be compared with the one obtained from patients affected by Alzheimer's and Parkinson's disease, validating our methodology as differential diagnostic tool for the discrimination of ALS from other neurological diseases
Evaluation of the spectral differences in the saliva of patients with bulbar or spinal ALS onset
Time frame: One Day
The intra-group analysis of recruited spinal and bulbar ALS patients will reveal the Raman fingerprint associated to the specific pathological subtype. This result will be important for the stratification of ALS patients after the ALS diagnosis.
Correlation of Raman data with clinical and paraclinical data
Time frame: One Day
Raman data related to the ALS group will be correlated with clinical and paraclinical data, validating in this way our methodology. Collected data will be correlated primarily with factors that can alterate the biochemical composition of saliva including age, smoking habit, time before the last meal, time before teeth brushing, percutaneous endoscopic gastrostomy, mechanical ventilation and others. Consequently the same data will be analysed finding correlations with ALS-FRS (Amyotrophic Lateral Sclerosis - Functional Rating Scale), WHO-QOL (World of Health Organization - Quality of Life), blood analysis outcome, time from the diagnosis and other
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 29308873Devitt G, Howard K, Mudher A, Mahajan S. Raman Spectroscopy: An Emerging Tool in Neurodegenerative Disease Research and Diagnosis. ACS Chem Neurosci. 2018 Mar 21;9(3):404-420. doi: 10.1021/acschemneuro.7b00413. Epub 2018 Feb 6.
- Background: PubMed 28552366van Es MA, Hardiman O, Chio A, Al-Chalabi A, Pasterkamp RJ, Veldink JH, van den Berg LH. Amyotrophic lateral sclerosis. Lancet. 2017 Nov 4;390(10107):2084-2098. doi: 10.1016/S0140-6736(17)31287-4. Epub 2017 May 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marzia Bedoni, PhD principal investigator
Fondazione Don Carlo Gnocchi ONLUS, Laboratory of Nanomedicine and Clinical Biophotonics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a new ALS biomarker in the saliva of people affected by Amyotrophic Lateral Sclerosis (ALS) using Raman Spectroscopy (time frame: One day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04233099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.