- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Taipei, Taiwan, 100
- Reclutamento
- National Taiwan University Hospital
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Sub-investigatore:
- Ann-Lii Cheng, PhD
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Sub-investigatore:
- Chih-Hung Hsu, PhD
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Sub-investigatore:
- Zhong-Zhe Lin, PhD
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Sub-investigatore:
- Ying-Chun Shen, PhD
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Sub-investigatore:
- Yu-Yun Shao, PhD
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Sub-investigatore:
- Rey-Heng Hu, PhD
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Sub-investigatore:
- Ming-Chih Ho, PhD
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Sub-investigatore:
- Chien-Hung Chen, PhD
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Sub-investigatore:
- Ja-Der Liang, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Numbers of circulating tumor cells
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sopravvivenza globale
Lasso di tempo: 24 mesi
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24 mesi
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Clinical characteristics
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Chiun Hsu, PhD, National Taiwan University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie dell'apparato digerente
- Malattie del fegato
- Neoplasie del fegato
- Processi neoplastici
- Metastasi neoplastica
- Carcinoma
- Carcinoma, epatocellulare
- Cellule Neoplastiche, Circolanti
Altri numeri di identificazione dello studio
- 201306057RIND
- ctcs201305 (Altro identificatore: Research Ethics Committee)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .