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临床试验/NCT05773196
NCT05773196招募中不适用

SAN-09611: Prospective Single-Timepoint Huntington's Disease Biospecimen Collection Study

Sanguine Biosciences1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5
试验地点
1
主要终点
Biospecimen Collection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Biospecimen Collection

时间窗: 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.

次要结局

  • Biorepository creation(6 months)

研究者

发起方
Sanguine Biosciences
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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