The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study
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Purpose
The investigators aim to recruit unaffected (healthy) people from families with a known genetic mutation in which at least two relatives have been affected with Amyotrophic Lateral Sclerosis (ALS). Our goal is to identify factors, both genetic and environmental, which put people at risk for developing ALS in the future.
| Condition |
|---|
|
Amyotrophic Lateral Sclerosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Pre-Familial Amyotrophic Lateral Sclerosis (Pre-fALS) Study |
- Risk Factors for Progression to familial ALS [ Time Frame: Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, plasma, CSF, DNA, urine, cell lines
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2006 |
Healthy people from familial ALS families with a known genetic mutation will be included in this study. The investigators encourage people who know that they carry the mutation that affects their family as well as those who do not know their genetic status to contact us. Those who wish to participate and to learn the results of genetic testing, may do so after undergoing genetic counseling. It is also possible to participate without learning the results of genetic testing. Participants in the study will travel to Miami (at our expense) on an annual basis.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Healthy individuals who harbor a mutation in a gene associated with ALS.
Inclusion Criteria
- A member of a family in which at least two relatives have been or currently are affected with ALS.
- The presence of a genetic change (mutation) in a gene associated with ALS, in a family member.
- No symptoms to suggest the presence of ALS (i.e. study participants must currently be healthy).
- Willingness to undergo genetic testing, with the option of whether or not to learn the results.
- Willingness to travel to Miami annually for in-person study evaluations.
Exclusion Criteria
- Diagnosis of ALS
Contacts and Locations| Contact: Eliana Reyes | 888-413-9315 | fALS@med.miami.edu |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Eliana Reyes 888-413-9315 fals@med.miami.edu | |
| Principal Investigator: | Michael G Benatar, MD, PhD. | University of Miami |
More Information
No publications provided
| Responsible Party: | Michael Benatar, MBChB, MS, DPhil, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00317616 History of Changes |
| Other Study ID Numbers: | 1369-2005 |
| Study First Received: | April 24, 2006 |
| Last Updated: | April 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Miami:
|
FALS SOD1 familial |
genetic testing genetic counseling ALS |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013