NCT03865420 Amyotrophic Lateral Sclerosis (ALS) Families Project
| NCT ID | NCT03865420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | ALS |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-09-11 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2018-09-11 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This program provides family members of individuals with familial ALS the opportunity to contribute to research focused on learning more about why motor neuron degeneration begins and how or why it progresses. This study provides genetic counseling and testing to help participants understand and manage their risk and determine if they want to learn their genetic status. This study will follow unaffected ALS gene mutation carriers on an annual basis to gather essential information that will ultimately help researchers develop novel therapies for the prevention and treatment of ALS.
Eligibility Criteria
Inclusion Criteria: * Men or women of any race or ethnicity aged 18 or older * No symptoms of ALS or fronto-temporal dementia at enrollment * Scenario 1: has already had genetic testing that identified an ALS-spectrum gene mutation. * Scenario 2: has a first degree relative who was/is an obligate carrier of a familial ALS-spectrum gene mutation. * Scenario 3: has a first degree relative who has/had an ALS-spectrum diagnosis who had a confirmed ALS-spectrum gene mutation or comes from a family with a high burden of ALS-spectrum diagnoses and a known ALS-spectrum gene mutation. * Scenario 4: is deemed to be at high risk for carrying an ALS-spectrum gene mutation as judged by a review of the family structure and genetic information by the study team. * Willing to undergo genetic analysis, with option of whether or not to learn results * Willing to travel to Columbia University Irving Medical Center (CUIMC) every 6-24 months for study procedures * Capable of providing informed consent and following study procedures, or has a legally authorized representative who is able to consent for the subject. Exclusion Criteria for participation in biosample portion of the study: * Known HIV * Known hepatitis B * Known hepatitis C
Contact & Investigator
Matthew Harms, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT03865420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 105 Years, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03865420 currently recruiting?
Yes, NCT03865420 is actively recruiting participants. Contact the research team at ALSFamiliesProject@cumc.columbia.edu for enrollment information.
Where is the NCT03865420 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03865420 clinical trial?
NCT03865420 is sponsored by Columbia University. The principal investigator is Matthew Harms, MD at Columbia University. The trial plans to enroll 300 participants.
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