Blood Specimen Collection Study for NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 主要终点
- Confirmative of Number of Participants with NAFLD Diagnosis
研究概览
简要总结
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy patients undergoing routine screening ultrasonography and from patients recently diagnosed with NAFLD.
详细描述
Accurate diagnosis of NAFLD combined with effective treatment improves survival and quality of life. Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay for accurate diagnosis of NAFLD. The study will collect blood sample from healthy patients undergoing routine screening ultrasonography and from patients recently diagnosed with NAFLD. A blood-based test for NAFLD could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and accurate diagnosis.
Three types of patients in this study:
Cohort A:
People ages 20-85 who have been recently diagnosed with (or strong clinical suspicion for) NAFLD. Blood samples must be collected before any treatment has been initiated.
Cohort B:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20-85 years of age
- •Recently completed ultrasonography examination.
- •Recently diagnosed with (or strong clinical suspicion for) primary NAFLD.
- •At least 7 days before but no more than 2 months after the most recent ultrasonography
- •Able and willing to provide blood samples per protocol
- •Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
排除标准
- •Alcohol abuse (weekly ethanol consumption: >140 g for men and >70 g for women) in the past year.
- •Personal history of NAFLD (other than most recent diagnosis)
- •Ultrasonography within the previous 9 years (other than most recent diagnosis)
- •A history of fatty liver or other liver diseases such as autoimmune hepatitis and drug-induced liver disease.
- •Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- •Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the ultrasonography.
- •If female, known to be pregnant.
- •Inclusion Criteria:
- •20-85 years of age
- •Planning to undergo a screening ultrasonography within 2 months after providing signed informed consent
- •Able and willing to provide blood samples per protocol
- •Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
- •Exclusion Criteria:
- •Alcohol abuse (weekly ethanol consumption: >140 g for men and >70 g for women) in the past year.
- •Personal history of NAFLD
- •Ultrasonography within the previous 9 years
- •A history of fatty liver or other liver diseases such as autoimmune hepatitis and drug-induced liver disease.
- •Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- •Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the ultrasonography.
- •If female, known to be pregnant.
- •Inclusion Criteria:
- •20-85 years of age
- •Recently completed ultrasonography examination.
- •Recently diagnosed with (or strong clinical suspicion for) NASH, an extremely advanced form of non-alcoholic fatty liver disease (NAFLD), defined as hepatic steatosis with inflammation and hepatocyte injury..
- •At least 7 days before but no more than 2 months after the most recent ultrasonography
- •Able and willing to provide blood samples per protocol
- •Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
- •Exclusion Criteria:
- •Alcohol abuse (weekly ethanol consumption: >140 g for men and >70 g for women) in the past year.
- •Personal history of NAFLD or NASH (other than most recent diagnosis)
- •Ultrasonography within the previous 9 years (other than most recent diagnosis)
- •A history of fatty liver or other liver diseases such as autoimmune hepatitis and drug-induced liver disease.
- •Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
- •Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the ultrasonography.
- •If female, known to be pregnant.
结局指标
主要结局
Confirmative of Number of Participants with NAFLD Diagnosis
时间窗: 2 months
Confirmative of number of Participants with NAFLD diagnosis in patients undergoing routine screening ultrasonography, or post-ultrasonography.
次要结局
未报告次要终点
研究者
James Shilling
Principal Investigator
HBI Solutions Inc.