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Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
Sponsor: Sanguine Biosciences
Summary
OBJECTIVES: The primary study objective is to collect blood from participants with Huntington's Disease in order to validate a CE marked Cytosine, Adenine, Guanine (CAG) assay for use in future studies for Huntington's Disease. The secondary study objective is to create a biorepository that can be used to identify disease associated biomarkers and potential targets with immune and multi-omics profiling. The disease sample collection and analysis will be the foundation for an extensive network of biospecimen access and linked datasets for future translational research.
Official title: SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
Key Details
Gender
All
Age Range
25 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
5
Start Date
2023-03-14
Completion Date
2025-02-28
Last Updated
2024-04-18
Healthy Volunteers
Not specified
Conditions
Interventions
Biospecimen Collection
Cohort 1-Huntington's Disease: The target blood volume of each phlebotomy visit will be 20 mL. The minimum accepted volume (in the event of tough venipuncture attempts or difficulty obtaining the blood) will be 5 mL. The maximum amount that can be drawn in a 6-week period will be 100 mL (whole blood 6-week maximum). Sample Collection: * 10 mL EDTA Vial (Box 1; Frozen) o Whole blood will be collected into 1 x 10 ml EDTA tube (no in-home/laboratory processing), shipped frozen (on dry ice) FedEx priority overnight (by 10:30 am) to Labcorp after each collection in box 1. * 10 mL EDTA Vial (Box 2; Ambient) * Whole blood will be collected into 1 x 10 ml EDTA tube (no in-home/laboratory processing), shipped ambient FedEx priority overnight (by 10:30 am) to Labcorp after each collection in box 2.
Locations (1)
Sanguine Biosciences, Inc.
Woburn, Massachusetts, United States