ALSMCSPNCT07400393
Healey ALS MyMatch Common Screening Protocol
An observational study of ALS and ALS (Amyotrophic Lateral Sclerosis), run by Massachusetts General Hospital.
Trial summary
The goal of the Healey ALS MyMatch Common Screening Protocol (MCSP), an observational study, is to identify individuals with ALS who may be eligible to be matched to a currently enrolling ALS MyMatch trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS, ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to 16 Mar 2029
- How long will I take part?
- 45 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target populations for MCSP and ALS MyMatch trials will initially focus on subgroups of individuals with ALS, including those with early-stage disease. Some ALS MyMatch trials will further target those with specific biomarkers or genetic markers for inclusion in a specific trial.
Who may be able to join
- Ability to provide written informed consent.
- Adults > 18 years of age.
- Diagnosis of symptomatic ALS that meets either the revised El Escorial Criteria.(clinically possible, probable, probable lab-supported, or definite) or the Gold Coast Criteria.
- Available or pending clinically obtained CLIA ALS genetic panel report.
- Time since onset of weakness due to ALS ≤ 24 months at the time of MCSP screening.
- Slow VC ≥ 65% of predicted capacity value for gender, height and age at screening.
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- Clinically unremarkable Complete Blood Counts as per SI's discretion, including but not limited to Hemoglobin ≥ 9 g/dL.
- Ability and willingness to complete all study procedures per SI's assessment.
- Negative pregnancy test at screening for women of child-bearing potential (WOCB), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months).
Who cannot join
- Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, per SI's assessment.
- Presence of cognitive or mental health disorders impairing ability to provide informed consent for the study per SI assessment.
- Active cancer or history of cancer, unless it was successfully treated for durable remission or cure more than 3 years ago. (Note that basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies that have been curatively excised at any time previously and with no evidence of disease recurrence for at least 3 years are not exclusionary.)
- Prior solid organ transplantation.
- Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the MCSP Screening Visit. (Please refer to the Manual of Procedures (MOP) for current list of experimental therapies)
- Screening 12-lead ECG showing QT interval corrected for rate (QTcF) > 470 msec for women and > 450 msec for men, absence of second degree or higher AV block or other clinically significant cardiac arrythmias.
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- Clinically significant abnormalities in the Comprehensive Metabolic Panel per SI's assessment, including but not limited to:
- Serum alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal, or serum bilirubin > 1.5 × upper limit of normal
- Estimated GFR (eGFR) of < 30 mL/min/1.73m2
- Other clinically significant electrolyte and metabolic abnormalities
- If female, breastfeeding, pregnant, or of child-bearing potential and unwilling to use effective contraception for duration of the trial and after discontinuing treatment as outlined in the ALS MyMatch trial protocol.
- Clinically significant unstable medical conditions (other than ALS) that would pose a risk to the participant, per SI's assessment (e.g., cardiovascular instability, systemic infection,), or clinically significant laboratory abnormality or ECG changes.
- Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).
- Participants who require Permanent assisted ventilation (PAV). PAV defined as more than 22 hours per day of noninvasive or invasive mechanical ventilation for more than seven consecutive days. The date of onset of PAV is the first day of the seven days.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Healey ALS MyMatch Common Screening Protocol (MCSP) for Determining Preliminary Eligibility for ALS MyMatch Early Phase Clinical Trials
The goal of the Healey ALS MyMatch Common Screening Protocol (MCSP), an observational study, is to identify individuals with ALS who may be eligible to be matched to a currently enrolling ALS MyMatch trial. Participants will complete a MCSP Screening Visit and undergo clinical assessments, laboratory testing, and biomarker analyses to determine preliminary trial eligibility. The study also characterizes clinical, genetic, and biofluid biomarker profiles, assesses the prevalence of ALS-associated gene variants, and banks blood samples for future ALS and biomarker research. MCSP enables simultaneous screening for multiple trial-specific biomarkers and uses a targeted medical history form to optimize matching of participants to appropriate MyMatch trials.
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, MyMatch, ALS MyMatch, MyMatch Program, MCSP, MyMatch Common Screening Protocol, Early Phase, Biomarker, Phase I, Phase II, Healey, NCRI, ALS Trials, MGB
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary eligibility to be matched to a MyMatch Trial
To determine preliminary eligibility of early ALS (< 24 months from weakness onset) participants for actively enrolling ALS MyMatch trial(s)
Measured: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial.
Secondary outcomes (3)
Repository for future research
To build an ALS biofluid, genetic and data repository for future clinical and translational research.
Measured: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Prevalence of gene mutations
To characterize the prevalence of participants with causative or risk modifier gene mutations in the MCSP
Measured: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Collect and bank samples
To collect and bank blood samples for future biofluid biomarker analyses
Measured: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startAug 2026 (estimated)
- Primary completion16 Mar 2029 (estimated)
- Study completion16 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 45 Days
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suma Babu, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400393
- Sponsor's protocol ID
- 2025P002080
- Acronym
- MCSP
- Status last verified
- Jul 2026
- First submitted
- 29 Jan 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healey ALS MyMatch Common Screening Protocol (MCSP) for Determining Preliminary Eligibility for ALS MyMatch Early Phase Clinical Trials
- ClinicalTrials.gov ID
- NCT07400393
- Acronym / sponsor ID
- MCSP / 2025P002080
- Keywords
- ALS, Amyotrophic Lateral Sclerosis, MyMatch, ALS MyMatch, MyMatch Program, MCSP, MyMatch Common Screening Protocol, Early Phase
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 16 Mar 2029 (estimated)
- Study completion
- 16 Mar 2029 (estimated)
- First posted
- 10 Feb 2026 (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.
The goal of the Healey ALS MyMatch Common Screening Protocol (MCSP), an observational study, is to identify individuals with ALS who may be eligible to be matched to a currently enrolling ALS MyMatch trial. Participants will complete a MCSP Screening Visit and undergo clinical assessments, laboratory testing, and biomarker analyses to determine preliminary trial eligibility. The study also characterizes clinical, genetic, and biofluid biomarker profiles, assesses the prevalence of ALS-associated gene variants, and banks blood samples for future ALS and biomarker research. MCSP enables simultaneous screening for multiple trial-specific biomarkers and uses a targeted medical history form to optimize matching of participants to appropriate MyMatch trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 45 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target populations for MCSP and ALS MyMatch trials will initially focus on subgroups of individuals with ALS, including those with early-stage disease. Some ALS MyMatch trials will further target those with specific biomarkers or genetic markers for inclusion in a specific trial.
Key inclusion criteria (9 listed)
- Ability to provide written informed consent.
- Adults > 18 years of age.
- Diagnosis of symptomatic ALS that meets either the revised El Escorial Criteria.(clinically possible, probable, probable lab-supported, or definite) or the Gold Coast Criteria.
- Available or pending clinically obtained CLIA ALS genetic panel report.
- Time since onset of weakness due to ALS ≤ 24 months at the time of MCSP screening.
Key exclusion criteria (14 listed)
- Clinically significant unstable medical or surgical condition that would pose a risk to the participant's trial procedural participation or interfere with data collection, per SI's assessment.
- Presence of cognitive or mental health disorders impairing ability to provide informed consent for the study per SI assessment.
- Active cancer or history of cancer, unless it was successfully treated for durable remission or cure more than 3 years ago. (Note that basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies that have been curatively excised at any time previously and with no evidence of disease recurrence for at least 3 years are not exclusionary.)
- Prior solid organ transplantation.
- Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the MCSP Screening Visit. (Please refer to the Manual of Procedures (MOP) for current list of experimental therapies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preliminary eligibility to be matched to a MyMatch Trial
Time frame: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial.
To determine preliminary eligibility of early ALS (< 24 months from weakness onset) participants for actively enrolling ALS MyMatch trial(s)
3 secondary outcomes
Repository for future research
Time frame: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Prevalence of gene mutations
Time frame: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Collect and bank samples
Time frame: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial. Samples will be banked indefinitely for future research on ALS and related diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS and ALS (Amyotrophic Lateral Sclerosis), run by Massachusetts General Hospital.
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 29 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Healey ALS MyMatch Clinical Operations Team (857-282-9210, mghalsmymatch@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary eligibility to be matched to a MyMatch Trial (time frame: From enrollment to the end of the 45-day MCSP screening period or at the end of completing a baseline visit for a MyMatch trial.). 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 29 Jul 2026.