- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Taipei, Taiwan, 100
- Rekrytering
- National Taiwan University Hospital
-
Underutredare:
- Ann-Lii Cheng, PhD
-
Underutredare:
- Chih-Hung Hsu, PhD
-
Underutredare:
- Zhong-Zhe Lin, PhD
-
Underutredare:
- Ying-Chun Shen, PhD
-
Underutredare:
- Yu-Yun Shao, PhD
-
Underutredare:
- Rey-Heng Hu, PhD
-
Underutredare:
- Ming-Chih Ho, PhD
-
Underutredare:
- Chien-Hung Chen, PhD
-
Underutredare:
- Ja-Der Liang, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
Arm A
HCC patients who receive curative surgery or radiofrequency ablation therapy
|
Arm B
patients who receive trans-arterial chemoembolization
|
Arm C
patients who receive systemic therapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Numbers of circulating tumor cells
Tidsram: in 24 months
|
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.
|
in 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Total överlevnad
Tidsram: 24 månader
|
24 månader
|
|
Clinical characteristics
Tidsram: in 24 months
|
The other clinical characteristics was defined as following characteristics:
|
in 24 months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Chiun Hsu, PhD, National Taiwan University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Neoplastiska processer
- Neoplasma Metastas
- Carcinom
- Karcinom, hepatocellulärt
- Neoplastiska celler, cirkulerande
Andra studie-ID-nummer
- 201306057RIND
- ctcs201305 (Annan identifierare: Research Ethics Committee)
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