Recruiting

Observational Study

Sponsor:

Sanguine Biosciences

Code:

NCT05773196

Conditions

Huntington Disease

Huntington's Dementia

Huntington Disease, Late Onset

Huntington; Dementia (Etiology)

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Study Details

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)

Study ID

NCT05773196

Start date

Mar 14, 2023

Status verified date

Apr, 2024

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Cohort 1: Huntington's Disease

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 25 to 65, inclusive
4. Participants have been diagnosed with Huntington's Disease
5. Patients must have numerical documentation of CAG repeats present in the Medical Record, along with a Huntington's Disease diagnosis.
6. 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:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. 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

Study Design

Enrollment

5 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Biospecimen Collection [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Andrew C Frisina, M.S.

9782394764Afrisina@sanguinebio.com

Locations

Sanguine Biosciences, Inc.

Recruiting

Woburn, Massachusetts, United States, 01801

Contacts

Andrew C Frisina, M.S.

978-239-4764Afrisina@sanguinebio.com

Principal Investigator:

Houman D Hemmati, MD

More Information

Sponsor

Sanguine Biosciences

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanguine Biosciences on 2024-04-18.