RecruitingNCT05773196

Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

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

Sponsor

Sanguine Biosciences

Enrollment

5 participants

Start Date

Mar 14, 2023

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Inclusion Criteria7

Cohort 1: Huntington's Disease
The participant is willing and able to provide written informed consent
The participant is willing and able to provide appropriate photo identification
Participants aged 25 to 65, inclusive
Participants have been diagnosed with Huntington's Disease
Patients must have numerical documentation of CAG repeats present in the Medical Record, along with a Huntington's Disease diagnosis.
Pre-existing evidence of CAG repeats should be in the range of 40-60 repeats \*Preference (not required for enrollment): Patients to have different CAG repeats from each other but this is not essential.\*

Exclusion Criteria4

Participants who are pregnant or are nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

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Interventions

OTHERBiospecimen 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.