- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
-
Underetterforsker:
- Ann-Lii Cheng, PhD
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Underetterforsker:
- Chih-Hung Hsu, PhD
-
Underetterforsker:
- Zhong-Zhe Lin, PhD
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Underetterforsker:
- Ying-Chun Shen, PhD
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Underetterforsker:
- Yu-Yun Shao, PhD
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Underetterforsker:
- Rey-Heng Hu, PhD
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Underetterforsker:
- Ming-Chih Ho, PhD
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Underetterforsker:
- Chien-Hung Chen, PhD
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Underetterforsker:
- Ja-Der Liang, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Numbers of circulating tumor cells
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Total overlevelse
Tidsramme: 24 måneder
|
24 måneder
|
|
Clinical characteristics
Tidsramme: in 24 months
|
The other clinical characteristics was defined as following characteristics:
|
in 24 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Chiun Hsu, PhD, National Taiwan University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Adenokarsinom
- Neoplasmer, kjertel og epitel
- Neoplasmer i fordøyelsessystemet
- Leversykdommer
- Neoplasmer i leveren
- Neoplastiske prosesser
- Neoplasma Metastase
- Karsinom
- Karsinom, hepatocellulært
- Neoplastiske celler, sirkulerende
Andre studie-ID-numre
- 201306057RIND
- ctcs201305 (Annen identifikator: Research Ethics Committee)
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