- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01034865
Risk Factors and Molecular Genomics of U.S. Patients With Chronic Liver Disease and Hepatocellular Cancer
Risk Factors and Molecular Genomics for Hepatocellular Carcinoma in U.S. Patients With Chronic Liver Disease: A Case Control Study
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
For Experimental Subjects Only:
Patients with HCC
For Controls Only:
Patients with chronic liver disease without evidence of HCC
Beskrivelse
Inclusion Criteria:
For both experimental subjects and controls:
- Patients between older than 18 years of age of all ethnic backgrounds and genders.
- Patients with chronic liver disease
For Experimental Subjects Only:
- Patients with HCC with a hepatic mass larger or equal to 5cm
- Patients with HCC with a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection
- Patients with HCC with a hepatic mass lesion with characteristic CT or MRI or angiographic appearance.
- For Controls Only:
Patients with chronic liver disease without evidence of HCC confirmed by either :
1. A normal AFP level
2. a negative imaging study (ultrasound, CT, or MR imaging).
3. Negative liver cancer on explants.
*Exclusion Criteria:
- Patients who declined to participate in the study
- Patients with a history of HIV infection
- Patients with concurrent advanced malignancy of non-hepatic origin.
- Patients with significant use of androgenic steroid.
- Patients with exposure to vinyl chloride.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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HCC PTS
Patients with HCC with either: (i) a hepatic mass larger or equal to 5cm, or; (ii) a hepatic mass lesion confirmed by fine needle aspirate (FNA) or by pathology in the cases of surgical resection, or; (iii) a hepatic mass lesion with characteristic CT or MRI or angiographic appearance.
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LD
Patients with chronic liver disease without evidence of HCC
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mindie H. Nguyen, Stanford University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SU-11022007-788
- 76873
- HEP0009 (Anden identifikator: Stanford)
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