Risk of Hepatocellular Carcinoma in Patient With Liver Cirrhosis
Study of Hepatocellular Carcinoma Risk in Patient With Liver Cirrhosis
연구 개요
상태
정황
상세 설명
Patients will be enrolled after hepatic ultrasonography control and they will be submitted to hepatic vein pressure gradient and liver biopsy.
The study have four research lines:
Task # 1: transcriptomic characterization of liver tissue. During hepatic vein pressure gradient , liver tissue will be extracted with transjugular catheter equipped with a biopsy device. Tissue will be used to extract microRNA to define molecular signature.
Task # 2: Proteomic characterization of liver tissue. Protein expression changes will be analyze with MALDI-TOF
Task # 3: Metabolomic features on serum of patient with cirrhosis. Metabolomics is defined as the quantitative measurement of the dynamic multiparametric response of living systems to pathophysiological stimulus or genetic modification. Principal objective of this activity will be identify metabolites deregulated with metabolomic approach and clarify any new pathways involved in the evolution of cirrhosis to hepatocellular carcinoma.
The metabolomic analysis will be performed on sera collected in patients with cirrhosis at baseline.
Task # 4: Transcriptomic characteristics of newly diagnosed HCC. New diagnosis of hepatocellular carcinoma will undergo an eco-assisted liver biopsy. A tissue sample will be dedicated to the extraction of 'RNA. Patients will then undergo elective treatment according to international guidelines. The course of the disease and the results of therapeutic interventions will be recorded and correlated with the molecular data. Molecular signature will be obtain.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
MO
-
Modena, MO, 이탈리아, 41124
- 모병
- Azienda Ospedaliera Universitaria Policlinico Di Modena
-
연락하다:
- ERICA VILLA, MD
- 전화번호: 0594225308
- 이메일: erica.villa@unimore.it
-
연락하다:
-
수석 연구원:
- ERICA VILLA, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with liver cirrhosis will be selected. After obtaining informed consent they will be submitted to hepatic biopsy,blood sample, HVPG with combined right heart catheterization and every 6 months to ultrasound.
Patients will be followed for 24 months thereafter or until the diagnosis of HCC, whichever comes first. In case of onset of HCC, will be performed a eco-guided biopsy.
설명
Inclusion Criteria:
- Obtaining written informed consent
- Liver cirrhosis
- Aged between 18 and 75 years
- Absence of exclusion criteria
Exclusion Criteria:
- HCC
- HIV
- Pregnancy
- Portal vein thrombosis
- Liver Transplant
- Patients' refusal to participate in clinical research
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Transcriptomics characterization of liver tissue: the purpose is molecular evaluation of possible predisposing factors to development of hepatocellular carcinoma in patients with cirrhosis.
기간: December 2017
|
RNA sample will be collected from patients and used to obtained transcriptomic profile through microarray and microRNA. Patients will be submitted to hepatic vein pressure gradient and combined right heart catheterization. During this standard procedure liver tissue will be taken and treated for extraction of RNA. In order to obtain microarray RNA extracted will be analyzed with single color hybridization of human RNA on Agilent Whole Human Genome Oligo whereas, the extraction of microRNA will be made starting from RNA extracted with mirVana miRNA Isolation kit. |
December 2017
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proteomic characterization of liver tissue: the objective is to understand if there is a relationship between emergence of HCC and alterations of protein expression in cirrhotic liver.
기간: DECEMBER 2017
|
Modifications of protein expression will be examined by two-dimensional electrophoresis and MALDI-TOF.
|
DECEMBER 2017
|
|
Metabolomic features of patient with cirrhosis: principal aim of this task is to identify particular metabolites and potential new pathway involved in the evolution of cirrhosis to hepatocellular carcinoma
기간: DECEMBER 2017
|
Analysis will be conducted on sera collected during the screening.
These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software
|
DECEMBER 2017
|
|
Transcriptomics characteristics of newly diagnosed hepatocellular carcinoma: the purpose is to verify if we can predict the survival of patients considering the molecular features of HCC at first diagnosis.
기간: DECEMBER 2017
|
Patients with new diagnosis of hepatocellular carcinoma will be subjected to liver biopsy.
A part of biopsy will be used to extract RNA and we will try to identify molecular signature through qRT / PCR (polymerase chain reaction) and using a set of 12 up- regulated and 10 down - regulated genes previously identified.
|
DECEMBER 2017
|
공동 작업자 및 조사자
수사관
- 수석 연구원: ERICA VILLA, Università di Modena e Reggio Emilia
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
암종, 간세포에 대한 임상 시험
-
Taichung Veterans General Hospital완전한심장 독성 | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung) | 의약품 관련 부작용 및 이상반응 (MeSH 용어) | Egfr 티로신 키나아제 억제제대만
-
Fondazione del Piemonte per l'Oncologia모병유방암 | 난소 암 | 대장암 | 흑색종(피부암) | 비소세포폐암 (MeSH 용어: Carcinoma, Non-Small-Cell Lung)이탈리아