Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study
New study seeks blood markers to help diagnose ALS early
Plain English Summary
Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study is a Not Applicable clinical trial sponsored by University Hospital, Tours studying ALS (Amyotrophic Lateral Sclerosis). This study is looking for specific markers in blood platelets that could help diagnose Amyotrophic Lateral Sclerosis (ALS). It is for individuals recently diagnosed with ALS or other motor neuron diseases. Participation involves providing blood samples for detailed analysis. Currently, there are no definitive blood tests for ALS, making early diagnosis challenging. The trial aims to enroll 60 participants.
Official Summary
The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Some non-specific biomarkers have been proposed (Neurofilaments, TDP-43) but their diagnostic value remains controversial. This study aims to identify ALS-specific platelet biomarkers using targeted and untargeted multi-omic approaches, in order to enable differential diagnosis between ALS and other motor neuron diseases.
Who Can Participate
Here is what you need to know about eligibility for this trial. You may be eligible if you are a man or woman aged 18-75 and have been diagnosed with ALS within the last 3 months, with symptoms starting less than 2 years ago. Individuals aged 18-75 diagnosed with another motor neuron disease within the last 3 months may also participate as controls. You cannot participate if you have genetic forms of ALS, are pregnant or breastfeeding, or are taking certain blood-thinning medications (except low-dose aspirin). Uncontrolled diabetes and certain legal or protective measures also exclude participation. This trial is studying ALS (Amyotrophic Lateral Sclerosis), so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure how well platelet markers can identify ALS at the time of diagnosis, helping to distinguish it from other similar conditions. The specific primary outcome measures are: Diagnostic potential of platelet biomarkers (Enrollment (< 3 months post-diagnosis)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find reliable blood markers for ALS, which could lead to earlier and more accurate diagnoses, improving patient management and treatment development. This research targets ALS (Amyotrophic Lateral Sclerosis), where improved treatment options are needed.
Investor Insight
This pilot study is a foundational step in biomarker discovery for ALS, a disease with a significant unmet medical need, potentially paving the way for future diagnostic tools.
Is This Trial Right for Me?
Ask your doctor if this study is a good fit for you, especially regarding your diagnosis timeline and current medications. Participation will involve providing blood samples at the study site. The study will track your condition over a period of time to see how the markers relate to disease progression. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 60 participants
Primary Outcomes
- Diagnostic potential of platelet biomarkers (Enrollment (< 3 months post-diagnosis))
Secondary Outcomes
- Diagnostic performances of platelet biomarkers compared to plasma neurofilaments (Enrollment (<3 months post-diagnosis))
- Relationships between platelet biomarkers, neurofilaments and clinical characteristics (Enrollment (<3 months post-diagnosis))
- Discriminatory capacity of platelet molecular signatures (Enrollment (<3 months post-diagnosis))
- Prognostic value of platelets biomarkers at diagnosis on ALS functional rating scale (ALSFRS-R) score progression after one year (Functional evolution between enrolment (<3months post-diagnosis) and 12 months)
Full Eligibility Criteria
Inclusion Criteria: Patients with ALS: * Men or women aged 18 to 75 * ALS diagnosed according to the El Escorial criteria * ALS diagnosis less than 3 months ago * Onset of symptoms defined as the time when muscle weakness was first observed by the patient less than 2 years ago Controls with another motor neuron disease: * Men or women aged 18 to 75 * Diagnosis of motor neuron disease \< 3 months Exclusion Criteria: * Genetic variants associated with ALS * Pregnant or breastfeeding women * Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day) * Uncontrolled diabetes * Persons deprived of their liberty by judicial or administrative decision * Persons subject to legal protection measures: guardianship or curatorship * Opposition to data processing
Trial Locations
- University hospital, Limoges, Limoges, France
- University hospital, Lyon, Lyon, France
- university hospital, Tours, Tours, France
Frequently Asked Questions
What is clinical trial NCT07479017?
NCT07479017 is a Not Applicable OBSERVATIONAL study titled "Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study." It is currently not yet recruiting and is sponsored by University Hospital, Tours. The trial targets enrollment of 60 participants.
What conditions does NCT07479017 study?
This trial investigates treatments for ALS (Amyotrophic Lateral Sclerosis). The primary condition under study is ALS (Amyotrophic Lateral Sclerosis).
What does Not Applicable mean for NCT07479017?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07479017?
This trial is currently "Not Yet Recruiting." It started on 2026-04. The estimated completion date is 2027-08.
Who is sponsoring NCT07479017?
NCT07479017 is sponsored by University Hospital, Tours. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07479017?
The trial aims to enroll 60 participants. The trial has not yet started recruiting.
How is NCT07479017 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07479017?
The primary outcome measures are: Diagnostic potential of platelet biomarkers (Enrollment (< 3 months post-diagnosis)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07479017 being conducted?
This trial is being conducted at 3 sites, including Limoges; Lyon; Tours (France).
Where can I find official information about NCT07479017?
The official record for NCT07479017 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07479017. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07479017 testing in simple terms?
This study is looking for specific markers in blood platelets that could help diagnose Amyotrophic Lateral Sclerosis (ALS). It is for individuals recently diagnosed with ALS or other motor neuron diseases.
Why is this trial significant?
This trial aims to find reliable blood markers for ALS, which could lead to earlier and more accurate diagnoses, improving patient management and treatment development.
What are the potential risks of participating in NCT07479017?
The primary risk is related to blood draws, such as bruising or minor discomfort. There are no known major risks associated with the biomarker analysis itself. Potential side effects are generally related to the blood collection process. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07479017?
Ask your doctor if this study is a good fit for you, especially regarding your diagnosis timeline and current medications. Participation will involve providing blood samples at the study site. The study will track your condition over a period of time to see how the markers relate to disease progression. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07479017 signal from an investment perspective?
This pilot study is a foundational step in biomarker discovery for ALS, a disease with a significant unmet medical need, potentially paving the way for future diagnostic tools. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing blood samples for detailed analysis. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.