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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Roma、イタリア
- University of Rome Sapienza
-
Rome、イタリア、00168
- Catholic University School of Medicine
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
Fine-needle liver biopsy
|
|
Healhy Donor
Fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls.
|
Fine-needle liver biopsy
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
The primary aim of our study is to validate blood non-invasivebiomarker sensitivity and accuracy in predicting NASH and fibrosis stage.
時間枠：2 months
|
2 months
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
NASH - 非アルコール性脂肪性肝炎の臨床試験
-
Université de SherbrookeCentre de recherche du Centre hospitalier universitaire de Sherbrooke; Centre hospitalier universitaire...募集非アルコール性脂肪性肝炎（NASH） | 肝線維症/NASH | 代謝機能不全に関連する脂肪性肝疾患 (MASLD)カナダ
-
Corcept Therapeutics募集非アルコール性脂肪性肝炎（NASH） | 非アルコール性脂肪肝疾患（NAFLD） | 代謝機能不全に関連する脂肪性肝疾患 (MASLD) | 代償性肝硬変を伴う代謝性機能不全関連脂肪性肝炎（MASH）/非アルコール性脂肪性肝炎（NASH）アメリカ
-
Active Genomes Expressed Diagnostics, CorpWalter Reed National Military Medical Center; Arizona Clinical Trialsまだ募集していません
-
The Affiliated Hospital of Hangzhou Normal University募集NAFLDとNASH | NAFLD（非アルコール性脂肪性肝疾患） | NAFLD 肝硬変中国
-
Consorcio Centro de Investigación Biomédica en...Hospital General Universitario Gregorio Marañon; Universidad Complutense de Madrid; Universidad... と他の協力者まだ募集していません
-
Badr Universityまだ募集していません
-
Hepion Pharmaceuticals, Inc.完了
-
Indiana UniversitySonic Incytes終了しました
Liver Biopsyの臨床試験
-
Kaiser PermanenteMassachusetts General Hospital; Stanford University; Cedars-Sinai Medical Centerまだ募集していません肝硬変 | MASLD - 代謝機能不全に関連する脂肪性肝疾患アメリカ
-
The University of Texas Health Science Center,...National Institute on Minority Health and Health Disparities (NIMHD)招待による登録
-
Aquyre Bioscience, IncBoston University; Fox Chase Cancer Center; Johnson & Johnson募集
-
University of Rome Tor Vergata完了