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

Huntington Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dementia
• Huntington Disease
• Huntington's Dementia

• NCT number: NCT05773196
• Study type: Observational
• Source: Sanguine Biosciences
• Contact: Andrew C Frisina, M.S.
• Phone: 9782394764
• Email: Afrisina@sanguinebio.com
• Status: Recruiting
• Start date: March 14, 2023
• Completion date: February 28, 2025