NCT05773196

Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5 (estimated)
• Sponsor: Sanguine Biosciences · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: —

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.

Detailed description

STUDY DESIGN: * This protocol is a single-center, single-cohort, bioresearch study enrolling up to 5 participants. The cohort is as follows: o Cohort 1: Huntington's Disease (n=5) * The study will enroll participants per the eligibility criteria. * Participants will have 1 scheduled biospecimen collection visit(s). If the participant requires a recollection or is called for an extra sample donation, this will add additional volume and visit(s) to the collection schedule. The biospecimens collected from participants are whole blood. * 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). * Confirmation of eligibility and medical record review by a member of the study staff will be completed for participants of the cohort before they are considered fully enrolled.

Conditions

• Huntington Disease
• Huntington's Dementia
• Huntington Disease, Late Onset
• Huntington; Dementia (Etiology)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-14
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-03-17
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States