- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01930383
Circulating Tumor Cells for Hepatocellular Carcinoma (CTCs for HCC)
Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma
Descripción general del estudio
Estado
Descripción detallada
Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.
Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy)
- to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
- to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
- to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital
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Sub-Investigador:
- Ann-Lii Cheng, PhD
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Sub-Investigador:
- Chih-Hung Hsu, PhD
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Sub-Investigador:
- Zhong-Zhe Lin, PhD
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Sub-Investigador:
- Ying-Chun Shen, PhD
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Sub-Investigador:
- Yu-Yun Shao, PhD
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Sub-Investigador:
- Rey-Heng Hu, PhD
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Sub-Investigador:
- Ming-Chih Ho, PhD
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Sub-Investigador:
- Chien-Hung Chen, PhD
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Sub-Investigador:
- Ja-Der Liang, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Patient must be diagnosed with HCC via one of following methods according to present clinical practice:
- Diagnosed as HCC by biopsy or cytology
- Patients with chronic hepatitis B or other reason induced liver cirrhosis who have diagnosed as HCC based on a typical contrast enhanced CT or MRI profile with malignant lesion [tumor hyper-vascularization].
- Asian male or female subjects >=20 years of age.
- Child-Pugh class A or B liver function..
- HCC patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current HCC practice guidelines) at National Taiwan University Hospital.
- Signed informed consent.
Exclusion Criteria:
- Other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Arm A
HCC patients who receive curative surgery or radiofrequency ablation therapy
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Arm B
patients who receive trans-arterial chemoembolization
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Arm C
patients who receive systemic therapy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Numbers of circulating tumor cells
Periodo de tiempo: in 24 months
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CTCs are measured by microfluidic disk platform.
They are defined as tumor cells that are circulating in the peripheral blood of patients, which are shed from either the primary tumor or its metastases.
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in 24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sobrevivencia promedio
Periodo de tiempo: 24 meses
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24 meses
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Clinical characteristics
Periodo de tiempo: in 24 months
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The other clinical characteristics was defined as following characteristics:
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in 24 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chiun Hsu, PhD, National Taiwan University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Adenocarcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias del Sistema Digestivo
- Enfermedades del HIGADO
- Neoplasias Hepaticas
- Procesos Neoplásicos
- Metástasis de neoplasias
- Carcinoma
- Carcinoma Hepatocelular
- Células Neoplásicas, Circulantes
Otros números de identificación del estudio
- 201306057RIND
- ctcs201305 (Otro identificador: Research Ethics Committee)
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