- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03200171
Effect of DAAs on Behavior of HCC in HCV Patients
Effect of Direct Acting Antiviral Agents on Behavior of Hepatocellular Carcinoma and Overall Survival in Patients With Chronic Hepatitis C
연구 개요
상세 설명
Introduction:
Chronic hepatitis C (HCV) infection can be complicated with liver cirrhosis and subsequently hepatocellular carcinoma (HCC). HCC develops at an annual rate of 1% to 4%, although higher rates up to 7% have been reported in Japan. Recently; Reig et al; noticed that there was an unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy (1). After this report; many publications have discussed the issue of HCC development and recurrence in HCV patients treated with interferon free regimens. Results of these trials are controversial with no definite conclusion till today. There is an unmet need for further study the effect of interferon free regimens on development of de novo HCC, recurrence of HCC and behavior of HCC in chronic HCV patients.
Aim of the study:
Investigators aim to study the effect of direct acting antiviral agents (DAAs) on behavior of hepatocellular carcinoma (HCC) and overall survival in patients with chronic hepatitis C (CHC).
Materials & methods:
Study Design: Prospective case control study
- Setting: Multicenter study
- Patients: 300 patients will be recruited in 2 groups assignment .
- Methods:
Procedure of data collection
The following data will be collected at base line for each patient:
- Medical history: including current and previous treatment with stress on History of treatment by DAAs (date started, used regimen, duration of treatment and treatment response)
- Full clinical examination
Laboratory Investigations:
- Complete blood picture (CBC):
- Liver profile: alanine aminotransferase (ALT), aspartate aminotransferase (AST), albumin, total and direct bilirubin, prothrombin time and international normalized ratio.
- Renal profile: serum blood urea nitrogen (BUN), creatinine, sodium and potassium levels.
- Hepatitis markers: hepatitis B surface antigen (HBs Ag) and hepatitis C virus antibody (HCV Ab).
- Alpha feto protein (AFP)
- Tri-Phasic spiral abdominal CT: to diagnose HCC by typical vascular pattern and to assess tumor extension.
- Biopsy if needed After confirming HCC diagnosis, included patients will be classified according to barcelona clinic liver cancer (BCLC) staging system and standard of care treatment will be provided to patients with different stages according to BCLC guidelines.
Follow up schedule:
Patients will be followed by CT scan or MRI examination and routine liver tests including AFP every 3 months during the first 2 years then every 6 months during the subsequent 3 years if no evidence of HCC recurrence during the first 2 years' period (for all patients regardless HCC treatment receipt and its type). Local recurrence will be defined as reappearance of tumor adjacent to the treated site of the initial HCC and distant recurrence as the emergence of one or several tumor(s) not adjacent to the treated zone. Criteria for the diagnosis of HCC recurrence will be the same as initial HCC, i.e. presence of typical hallmark of HCC according to European Association for the Study of the Liver - European Organisation for Research and Treatment of Cancer (EASL-EORTC) guidelines and defined by presence on imaging of hyper vascular in the arterial phase with washout in the portal venous or delayed phases. All imaging exams will be centralized and assessed by the same radiologist.
Analysis of results:
- Statistical analysis will aim at identifying factors leading to change of behavior of HCC after DAAs in CHC patients in addition to determination of the overall survival in those patients.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Cairo, 이집트, 11651
- MOHAMED Alboraie
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Cairo, 이집트
- Helwan University
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Cairo, 이집트
- National Hepatology and Tropical Medicine Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with HCV related Hepatocellular carcinoma (HCC); all patients with confirmed diagnosis of HCC according to EASL-EORTC guidelines who attend HCC outpatient clinics in the study centers will be enrolled after signing informed consent. Patients will be then assigned into two main comparison groups:
- Group I: HCC patients who received DAAs for chronic HCV previously (either responders or not)
- Group II: HCC patients who are naive to DAAs.
Exclusion Criteria:
- Patients who refuse to be enrolled in the study.
- Patients with hepatitis B virus or any other causes of cirrhosis.
- Other prior malignancy without complete remission in the last five years, with the exception of adequately treated basal cell carcinoma or in situ cervical cancer; in case of other prior malignancy, the diagnosis of HCC has to be histologically proven.
- HCC developed on transplanted liver.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Group I
HCC patients who received DAAs for chronic HCV previously (either responders or not)
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Group II
HCC patients who are naive to DAAs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall survival (OS)
기간: 6 months - 3 years
|
he length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
|
6 months - 3 years
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Behavior of hepatocellular carcinoma
기간: 6 months - 3 years
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Early recurrence, or rapid progression
|
6 months - 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Progression-free survival (PFS)
기간: 6 months - 3 years
|
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Progression-free survival (PFS) will be measured by the Independent Radiological Review according to RECIST 1.1.
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6 months - 3 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mohamed Alboraie, M.D., Al-Azhar University
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EARTH-HCC-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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