SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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)
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The study will enroll participants per the eligibility criteria.
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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.
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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).
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Cohort 1: Huntington's Disease
Inclusion:
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The participant is willing and able to provide written informed consent
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The participant is willing and able to provide appropriate photo identification
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Participants aged 25 to 65, inclusive
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Participants have been diagnosed with Huntington's Disease
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Patients must have numerical documentation of CAG repeats present in the Medical Record, along with a Huntington's Disease diagnosis.
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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:
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Participants who are pregnant or are nursing
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Participants with a known history of HIV, hepatitis, or other infectious diseases
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Participants who have taken an investigational product in the last 30 days
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanguine Biosciences, Inc. | Woburn | Massachusetts | United States | 01801 |
Sponsors and Collaborators
- Sanguine Biosciences
- Hoffmann-La Roche
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAN-09611