- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05773196
Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study (SAN-09611)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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)
- 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Andrew C Frisina, M.S.
- Phone Number: 9782394764
- Email: Afrisina@sanguinebio.com
Study Locations
-
-
Massachusetts
-
Woburn, Massachusetts, United States, 01801
- Recruiting
- Sanguine BioSciences, Inc.
-
Contact:
- Andrew C Frisina, M.S.
- Phone Number: 978-239-4764
- Email: Afrisina@sanguinebio.com
-
Principal Investigator:
- Houman D Hemmati, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Cohort 1: Huntington's Disease
Inclusion:
- 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:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biorepository creation
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Disease Attributes
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Cognition Disorders
- Chorea
- Dementia
- Huntington Disease
- Late Onset Disorders
Other Study ID Numbers
- SAN-09611
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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