Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

Recruiting

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

• Registration Number: NCT05773196
• Lead Sponsor: Sanguine Biosciences

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Study Start: 2023-03-14
• Study First Posted: 2023-03-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biospecimen Collection	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Biorepository creation	6 months	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.

Trial Locations

Locations (1)

Sanguine Biosciences, Inc.; 🇺🇸 Woburn, Massachusetts, United States