ALS Biorepository Collection

The ALS Registry Act (H.R. 2295) was passed on October 16, 2008. The ALS Registry Act amends the Public Health Service Act to require the Secretary of DHHS, acting through the Director of CDC/ATSDR, to (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS); and (2) establish a national registry for the collection and storage of ALS data. In October, 2010, ATSDR officially launched the National ALS Registry. The purpose of the ALS Registry is to better describe the incidence and prevalence of ALS in the United States; examine factors, such as environmental and occupational, that might be associated with the disease; better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and facilitate examination of the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS. In November 2018, ATSDR released its most current National ALS Registry prevalence report for 2015 which showed 16,583 cases for a prevalence rate of 5.2 cases of ALS per 100,000 persons in the U.S. general population. In addition to tracking new ALS cases, ATSDR is now engaging in a series of activities to further enhance the National ALS Registry. Examples already underway include launching new survey modules to help identify potential risk factors for ALS, funding investigator intiated R01 grants, connecting patients with clinical trials and epidemiological studies, and using comprehensive surveillance activities in select states and large metropolitan areas to help test the completeness of the Registry. Because little is known about the role genetics plays in ALS, ATSDR conducted a pilot study to determine the feasibility of establishing a biorepository of samples from persons with ALS. Samples from approximately 330 patients have been collected, including blood, urine, hair, and nails samples, as well as post-mortem specimens from up to 30 patients, such as whole brains, spinal cords, and cerebrospinal fluid. The findings of that pilot study indeed support the creation of a biorepository. The purpose of this contract is to maintain and continue a national biorepository of specimens from persons with ALS enrolled in the National ALS Registry. ATSDR is particularly interested in samples such as blood, urine, saliva, hair, and nails, in addition to port-mortem specimens such as bone, muscle, skin, whole brains, spinal cords, and cerebrospinal fluid (CSF). Note, these speciments are subject to change. Collected samples (already collected and future collections) may be used for the purpose of creating cell lines. While there are other biorepositories currently in existence that contain specimens from persons with ALS, these biorepositories are often limited and target select groups (e.g., military veterans with ALS). Additionally, these biorepositories do not necessarily collect epidemiological/risk factor data from the patients who contribute specimens (e.g., occupational, residential, and military history). Submission of specimens for this biorepository would be open to all persons with ALS enrolled in the congressionally mandated National ALS Registry. The ability to connect the biological material to information about risk factors and data about medical treatment will make the biorepository unique and especially valuable to ALS researchers. This contract will provide funding for the operation, collection, transport, maintenance, cataloging, logistics, and ongoing analyses as directed by ATSDR of sample supply and demand of an existing biorepository of specimens from persons with ALS enrolled in the National ALS Registry.