Healey ALS MyMatch Common Screening Protocol
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
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.Secondary outcomes
1
Repository for future research
To build an ALS biofluid, genetic and data repository for future clinical and translational 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.2
Prevalence of gene mutations
To characterize the prevalence of participants with causative or risk modifier gene mutations in the MCSP
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.3
Collect and bank samples
To collect and bank blood samples for future biofluid biomarker analyses
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: