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RECRUITING
NCT05773196

Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

Sponsor: Sanguine Biosciences

View on ClinicalTrials.gov

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

Interventions

OTHER

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