Amyotrophic Lateral SclerosisDIAGALSNCT06230562
DIAGALS: Relation Between Tar DNA Binding Protein(TDP)-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease
A study testing Blood sample in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours.
Trial summary
In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Aug 2025
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years old
- Person affiliated to a French social security scheme or equivalent
- ALS diagnosed according to El Escorial criteria
- Diagnosis of ALS < 6 months
- Onset of symptoms < 2 years
- Signed informed consent
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- Non-inclusion criteria :
- Pregnant or breast-feeding
- Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
- Unbalanced diabetes
- Long-term corticosteroid therapy
- Persons deprived of their liberty by judicial or administrative decision; Persons under legal protection: guardianship or curators
- Genetic mutations associated with ALS
- Control group :
- Male or female volunteer aged 18 or over
- Person affiliated to a French social security scheme or equivalent
- Signed informed consent
- Non-inclusion criteria :
- Pregnant or breast-feeding women
- Treatment with oral or injectable anticoagulants, antiplatelet agents (except aspirin at the maximum authorized dosage of 160 mg per day)
- Unbalanced diabetes
- Long-term corticosteroid therapy
- Neurological diseases
- Patient under legal protection (safeguard of justice, curators and guardianship), or in a situation of deprivation of liberty
- Genetic mutations associated with ALS
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: DIAGALS: Relation Between TDP-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease: Prospective, Bicentric, Non-randomized, Open-label Study
In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of several studies and the modulatory effect of TDP-43 on the Nrf-2 pathway. Since both TDP-43 and Nrf-2 proteins are present in the peripheral blood mononuclear cells (PBMC) of ALS patients and may be correlated with disease progression, the investigators wish to explore their relationship and their application in the clinic as potential blood biomarkers for ALS.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Blood sample
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
The intervention is to take a blood sample every 6 months for 1 year which is not part of health routine care
Blood sampleBiological
The intervention is to take a blood sample at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Not described Receives: Biological: Blood sample |
| Control group | Active comparator | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of TDP-43 aggregates in PBMC
Peripheral blood samples from ALS patients and controls will be collected at inclusion and at follow-up visits for patients.
PBMC isolation and monocyte/lymphocyte enrichment will be performed using a Percoll gradient or magnetic bead separation.
Measured: Evolution between baseline and 6 month
PBMC accompanied by a protein expression profile under Nrf-2 control
From blood samples, RNA will be extracted from PBMCs and expression of Nrf-2 target genes will be analyzed by flow cytometry.
Measured: Evolution between baseline and 6 month
Secondary outcomes (1)
Provide a method for identifying TDP-43 in PBMC bly flow cytometry.
From blood samples, use of antibody fragments that recognize TDP-43 in the cell cytoplasm.
Measured: At 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230562
- Sponsor's protocol ID
- DR230136
- Acronym
- DIAGALS
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAGALS: Relation Between TDP-43 et Nrf-2 in ALS: a Track to Improve Diagnosis and Prognosis of the Disease: Prospective, Bicentric, Non-randomized, Open-label Study
- ClinicalTrials.gov ID
- NCT06230562
- Acronym / sponsor ID
- DIAGALS / DR230136
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Jan 2024 (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.
In response to oxidative stress, cells activate the Nrf-2 pathway, which induces translation of its target genes and corresponding proteins involved in the antioxidant response. This explains the interest in the Nrf-2 pathway in the pathophysiology of Amyotrophic lateral sclerosis (ALS), supported by the results of several studies and the modulatory effect of TDP-43 on the Nrf-2 pathway. Since both TDP-43 and Nrf-2 proteins are present in the peripheral blood mononuclear cells (PBMC) of ALS patients and may be correlated with disease progression, the investigators wish to explore their relationship and their application in the clinic as potential blood biomarkers for ALS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Biological: Blood sample |
| Control group | Active comparator | Biological: Blood sample |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Men and women ≥ 18 years old
- Person affiliated to a French social security scheme or equivalent
- ALS diagnosed according to El Escorial criteria
- Diagnosis of ALS < 6 months
- Onset of symptoms < 2 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood sampleThe intervention is to take a blood sample every 6 months for 1 year which is not part of health routine care | Biological | Case group |
| Blood sampleThe intervention is to take a blood sample at baseline. | Biological | Control group |
Primary outcome
Presence of TDP-43 aggregates in PBMC
Time frame: Evolution between baseline and 6 month
Peripheral blood samples from ALS patients and controls will be collected at inclusion and at follow-up visits for patients. PBMC isolation and monocyte/lymphocyte enrichment will be performed using a Percoll gradient or magnetic bead separation.
PBMC accompanied by a protein expression profile under Nrf-2 control
Time frame: Evolution between baseline and 6 month
From blood samples, RNA will be extracted from PBMCs and expression of Nrf-2 target genes will be analyzed by flow cytometry.
1 secondary outcome
Provide a method for identifying TDP-43 in PBMC bly flow cytometry.
Time frame: At 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours.
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 25 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie Mousset (+33247474665, e.mousset@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of TDP-43 aggregates in PBMC (time frame: Evolution between baseline and 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2024.