Huntington DiseaseSAN-09611NCT05773196
Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
An observational study of Huntington Disease and Huntington's Dementia, run by Sanguine Biosciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Huntington Disease, Huntington's Dementia, Huntington Disease, Late Onset
- What is being tested?
- Biospecimen Collection
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.*
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sanguine Biosciences, Inc.
Woburn, Massachusetts, 01801
Andrew C Frisina, M.S., 978-239-4764, Afrisina@sanguinebio.com
Houman D Hemmati, MD
About this study
Official title: SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
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.
Read the detailed description
STUDY DESIGN:
- This protocol is a single-center, single-cohort, bioresearch study enrolling up to 5 participants. The cohort is as follows:
- 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.
- Conditions
- Huntington Disease, Huntington's Dementia, Huntington Disease, Late Onset, Huntington; Dementia (Etiology)
- Being tested
- Biospecimen Collection
- Medical subject headings
- Huntington Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
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)
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Biorepository creation
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start14 Mar 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773196
- Sponsor's protocol ID
- SAN-09611
- Acronym
- SAN-09611
- Status last verified
- Apr 2024
- First submitted
- 6 Mar 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data provided to Roche only.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study
- ClinicalTrials.gov ID
- NCT05773196
- Acronym / sponsor ID
- SAN-09611 / SAN-09611
- Conditions
- Huntington Disease, Huntington's Dementia, Huntington Disease, Late Onset, Huntington; Dementia (Etiology)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionCohort 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. | Other | – |
Primary outcome
Biospecimen Collection
Time frame: 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.
1 secondary outcome
Biorepository creation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No. Data provided to Roche only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease and Huntington's Dementia, run by Sanguine Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew C Frisina, M.S. (9782394764, Afrisina@sanguinebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen Collection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 1 Nov 2026.