- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04677101
Liquid Biopsy for NASH and Liver Fibrosis (LIBRA)
Liquid Biopsy as a Non-invasive Tool for the Diagnosis of NASH and Liver Fibrosis
Nonalcoholic fatty liver disease (NAFLD) has evolved to represent the most common cause of chronic liver disease globally. Today, NAFLD is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (HCC) in the United States. NAFLD is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (NASH), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression.
Currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. However, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. Other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity.
Despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. Blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings.
Recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. In fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.
연구 개요
상세 설명
This is a multicentric prospective observational study to validate blood non-invasive biomarkers for NASH and fibrosis stage.
150 subjects will be enrolled; 100 subjects with biopsy-proven NASH and 50 subjects with normal liver will be used as controls.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Roma, 이탈리아
- University of Rome Sapienza
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Rome, 이탈리아, 00168
- Catholic University School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
설명
Inclusion Criteria:
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
Exclusion Criteria:
Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (>20 g/day for women or >30 g/day for men); Wilson's disease; Lipodystrophy; Parenteral nutrition; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Subjects with NASH documented by liver biopsy
One hundred subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI ≥30 and ≤55 kg/m2.
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Fine-needle liver biopsy
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Healhy Donor
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
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Fine-needle liver biopsy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary aim of our study is to validate blood non-invasivebiomarker sensitivity and accuracy in predicting NASH and fibrosis stage.
기간: 2 months
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2 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
NASH - 비알코올성 지방간염에 대한 임상 시험
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Galmed Pharmaceuticals LtdQuotient Sciences완전한
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Enanta Pharmaceuticals, Inc완전한
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Milton S. Hershey Medical Center아직 모집하지 않음간 질환 | NASH - 비알코올성 지방간염 | NASH
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Milton S. Hershey Medical Center모병
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음섬유증 | 경화증 | NAFLD | NASH - 비알코올성 지방간염 | NASH
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University of OxfordAssistance Publique - Hôpitaux de Paris; University of Nottingham; Novartis; Pfizer; University... 그리고 다른 협력자들모병NAFLD | 섬유증, 간 | NASH - 비알코올성 지방간염 | NASH | 간 지방증핀란드, 영국, 그리스, 독일, 스웨덴, 스페인, 이탈리아, 스위스, 미국, 프랑스