The ALL ALS Consortium (ALL ALS) collects valuable biospecimens from people living with ALS, people living without ALS, and individuals at genetic risk for developing ALS to support research aimed at better understanding ALS, identifying biomarkers, and accelerating future discoveries.
To ensure these biospecimens are carefully managed and preserved, ALL ALS partners with the BioSEND (Biospecimen Exchange for Neurological Disorders), a centralized biorepository specializing in the collection, processing, storage, and distribution of biospecimens for neurological disease research.
BioSEND plays an important role in maintaining the quality and long-term availability of ALL ALS’s biospecimens collected through the study. To ensure that each sample can be used to support critical research, BioSEND adopts standardized sample handling, storage, and distribution processes.
Biospecimens are small samples of a biological material, such as tissue, blood, saliva, or urine. Biospecimens are collected for a variety of purposes and are used to conduct standard clinical tests and to execute critical research studies.
A biomarker is a measurable indicator of a biological process, either a normal process or one related to disease. Biomarkers are used to diagnose disease, monitor health, and guide treatment. Biomarkers may be found in biospecimens, like blood or spinal fluid. They can also be found through common clinical tests, such as a blood pressure test, or imaging, such as an MRI.
ALL ALS participants provide routine blood and optional spinal fluid samples.
These collected biospecimens will be processed into their component parts. For example, whole blood can be processed into plasma, serum, peripheral blood mononuclear cells (PBMCs), and various genetic material.
Biospecimens provide researchers with valuable information about the biological changes associated with ALS onset, development, and progression. In addition, biospecimens can be securely linked to clinical data, such as physical test results and survey responses, which amplifies their collective impact and expands opportunities for potential research discoveries.
Biospecimens collected through ALL ALS may help researchers:
When a participant provides a biospecimen through ALL ALS, several steps occur to ensure that the sample remains valuable for research:
Biospecimens are collected by trained and certified clinicians and research professionals, according to standardized study procedures.
Research professionals carry out simple processing measures to ensure the biospecimens’ integrity is maintained throughout the shipment process. Each biospecimen is labeled with a unique barcode. The biospecimens BioSEND in Indianapolis, IN within 2 weeks of the completed study visit.
Upon arrival at BioSEND, expert laboratory technicians scan each barcoded biospecimen into a database to track storage location, temperature, and additional processing. Some of the biospecimens undergo additional processing, such as DNA or RNA extraction or stem cell isolation.
Processed biospecimens are securely stored at BioSEND. Access to the laboratory spaces and database is strictly limited.
Researchers may request access to biospecimens to conduct ALS-related research studies. BioSEND has processes in place to review and approve requests and provide access to qualified researchers.
BioSEND was created and is funded by the National Institutes of Health (NIH) to serve as a large biorepository for research studies of neurological disorders and conditions. Using a central biorepository ensures biospecimens and results from biospecimen testing are comparable across many studies.
The ALL ALS biospecimens may be requested by any qualified researcher who is studying ALS biomarkers, including researchers at pharmaceutical companies or researchers based in other countries. The researcher must submit an application which is reviewed by a committee of experts in ALS, biomarkers, and statistics. When reviewing each application, the committee considers the feasibility of the study, expertise of the investigator, and justification of use of the ALL ALS samples.
No. The biospecimens and data collected from you are assigned an ID code. Researchers who access biospecimens do not have access to the “key” that links your identity or any personal information to that code. If you would like to learn more about how ALL ALS protects your information, visit our Participant Data and Information Security research page.
The BioSEND staff who handle your specimens are trained to follow carefully developed Standard Operating Procedures (SOPs). These SOPs govern every step of biospecimen handling and processing to ensure the quality of each specimen is maintained. Your specimens are held in freezers set to -80° C. These freezers are monitored 24/7.
All biospecimens are stored at -80°C (or below) to prevent breakdown of biomarkers. By maintaining the biospecimens at ultra-low temperatures, we ensure they will be valuable to research for many years to come.
While we cannot share information on whether and how your individual biosamples are being utilized in research, details of all approved requests for ALL ALS samples are publicly available. Summaries of research projects utilizing biospecimens from ALL ALS will be posted on the ALL ALS website.