Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

NCT05773196 | Recruiting

• 1 other identifier: SAN-09611
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Biospecimen Collection

  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.

  6 months

Secondary Outcomes (1)

• Biorepository creation

  6 months

Interventions

Biospecimen Collection OTHER

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.

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The biospecimen subtypes for this study include whole blood from people diagnosed with Huntington's disease. The global prevalence and rising burden of Huntington's disease is a worldwide healthcare concern. Huntington's Disease is seen as frequently in 10.6-13.7 people per 100,000 individuals.10 The collection and analysis of samples from the diseased specimens will lay the groundwork for an extensive network of biospecimen access and linked datasets for future translation research in therapeutic development and a better understanding of the disease to improve health outcomes.

You may qualify if:

• 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.\*

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanguine Biosciences: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Sanguine Biosciences, Inc.

Woburn, Massachusetts, 01801, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Huntington Disease; Dementia

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Andrew C Frisina, M.S.

CONTACT

9782394764; Afrisina@sanguinebio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: March 14, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)