- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02358070
Epidemiologic Study of Hepatocellular Carcinoma in the US
The purpose of this study is:
- to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance.
- to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search.
- to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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California
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Stanford, California, Vereinigte Staaten, 94305
- Stanford Liver Transplant Clinic
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
All patients with Hepatocellular Carcinoma in New Jersey and Connecticut as well as selected patients in New York, Hawaii and northern California.
Healthy volunteers will comprise a random sample of New Jersey and Connecticut residents as controls.
Beschreibung
Inclusion Criteria for HCC cases:
- a diagnosis of primary liver cancer (excluding secondary tumors)
- a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder)
- a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence)
- a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer;
- age at diagnosis between 35 and 84 years
- living in Connecticut, New Jersey, New York, or Hawaii for at least a year as regular residents.
Exclusion Criteria for HCC cases:
- uncertain diagnoses or classification of malignancy, such as unknown origin
- a diagnosis of primary tumors in other organs, not in the liver
- unable to communicate well enough in English or Spanish
- having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent.
- diagnosed at age <35 years or >84 years
- temporary residents of New Jersey, Connecticut, New York, or Hawaii
Inclusion Criteria for control subjects:
- age between 35 and 84 years
- living in New Jersey or Connecticut for at least a year as regular residents
- able to communicate well in English or Spanish
- having no medical conditions, such as mental disorders, that prevent them from providing adequately comprehensible information
- potential subjects with a previous history of cancer are eligible.
Exclusion Criteria for control subjects:
- age < 35 years or > 84 years
- temporary residents of New Jersey or Connecticut
- unable to speak English or Spanish
- cannot provide adequately comprehensible information
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Kontrollgruppe
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HCC group
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Lifetime physical activity
Zeitfenster: 20 years
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Lifetime physical activity will be measured by collecting data on major types of physical activity separately and by determining frequency, intensity, and duration of each activity using a combined modification of Friedenreich's lifetime physical activity questionnaire and Kriska's past year physical activity questionnaires.
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20 years
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Energy intake
Zeitfenster: 20 years
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A modified Food Frequency questionnaire based on one developed by Dr. Alan Kristal from the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle will capture energy intake by differentiating low-fat food options from higher-fat counterparts.
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20 years
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Lifestyle factors
Zeitfenster: 20 years
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Structured questionnaires will be used to elicit information on demographic, anthropometric, and socioeconomic factors, long-term use of medications, medical history, and family history of cancer, cigarette smoking and alcohol consumption, physical activity, and dietary habits.
Additional information unrelated to liver cancer will be included in the questionnaire to help assess possible recall bias.
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20 years
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mindie Nguyen, MD, Stanford University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HEP0049
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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