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Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study) (NoFlic)

21. februar 2019 opdateret af: University Hospital, Bordeaux

Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver (NoFlic Study)

The main objective of this study is to identify direct carcinogenic factors in the absence of cirrhosis, and the carcinogenesis pathways involved on nonfibrotic liver (NfCHC).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Most hepatocellular carcinoma (HCC) complicates cirrhosis, which is often caused by infection with hepatitis B or C viruses, alcohol, obesity, exposure to aflatoxin B1 (AFB1) or hemochromatosis. Nevertheless, 10 to 40% of HCCs can develop on non-cirrhotic terrain and about 5% on nonfibrotic liver (NfHCC). In 20 to 40% of these NfHCCs, no classical HCC risk factor is identified. Some cases could be the result of a transformation of an adenoma. Others may be associated with yet non-formally identified toxins and / or a specific genetic predisposition. While there is a lot of data on alterations of signaling pathways (ß-catenin, AKT / mTOR, Ras / pERK, etc.) in "classical" HCCs, altered pathways remain unknown in most NfHCCs, even in some cases, activation of β-catenin, inactivating mutations of HNF1 or activators of gp130 have been shown. A specific study of NfHCCs, rather rare cancers, represents an opportunity to look for directly carcinogenic factors in the absence of cirrhosis, and to dissect the involved carcinogenesis pathways.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

283

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Amiens, Frankrig
        • CHU Amiens
      • Bondy, Frankrig
        • AP-HP Jean Verdier
      • Bordeaux, Frankrig
        • CHU Bordeaux
      • Caen, Frankrig
        • CHU Caen
      • Clamart, Frankrig
        • AP-HP Hôpital Antoine Beclere
      • Clichy, Frankrig
        • AP-HP Hôpital Beaujon
      • Créteil, Frankrig
        • CHi Creteil
      • Grenoble, Frankrig
        • CHU Grenoble
      • Lyon, Frankrig
        • Hôpital Edouard Herriot
      • Lyon, Frankrig
        • Hospices Civiles de Lyon
      • Paris, Frankrig
        • AP-HP Cochin
      • Paris, Frankrig
        • AP-HP Hopital Saint Antoine
      • Paris, Frankrig
        • AP-HP Hopital Henri Mondor
      • Villejuif, Frankrig
        • CHU Villejuif

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

CASES: patients with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2)

- CONTROLS: patients without NfHCC at baseline

Beskrivelse

Inclusion Criteria:

  • CASES: patients aged 18 years and older with a diagnosis of NfHCC with anatomopathological examination and showing a HCC according to standard histopathological criteria and an absence of significant fibrosis in non-tumoral tissues with the METAVIR system score or equivalent (F0 or F1) or the Kleiner et al stage of ASH and NASH (≤stade 2); signed informed consent; affiliated or beneficiary of a social security system
  • CONTROLS: patients aged 18 years and older without NfHCC at baseline; patients for whom an endoscopy is programmed as part of an assessment of intestinal functional disorders, dyspeptic disorders or screening colonoscopy or hospitalized patients in orthopedic surgery / traumatology or rheumatology departments; signed informed consent; affiliated or beneficiary of a social security system

Exclusion Criteria:

  • CASES: HCC diagnosed without pathological examination; hepatic transplantation before the diagnosis of HCC; patients unable to answer questions; patients who do not speak French or live abroad.
  • CONTROLS: History of liver cancer; other cancers under treatment except cutaneous cancers; Colonoscopy indicated in case of familial form of colon cancer; patient with cirrhosis; patients unable to answer questions; patients who do not speak French or live abroad; Relationship or same home with the case

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cases: patients with hepatocellular carcinoma on non-cirrhotic
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
Control: patients without hepatocellular carcinoma
Blood test and self-administrated questionnaires (medical history of the participant and his / her family, tobacco consumption, alcoholic and non-alcoholic beverages consumption, eating habits, type of employment and exposure, stays abroad longer than 1 month
Andet: Blood test and self-administrated questionnaires

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
exposure to Viral hepatitis B
Tidsramme: Baseline
binary yes / undiagnosed by positive serology for anti-HBc antibodies isolated or associated with positive serology for anti-HBs antibodies
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
exposure to viral hepatitis C
Tidsramme: baseline
binary yes / undiagnosed by positive serology for positive anti-HCV antibodies
baseline

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
exposure to Alcohol
Tidsramme: baseline
binary variable, separating large consumers from others
baseline
exposure to Exogenous female hormones
Tidsramme: baseline
oral contraceptive coded as a binary variable
baseline
history of liver pathology
Tidsramme: baseline
binary variable: yes/no
baseline
Family history of liver cancer
Tidsramme: baseline
binary variable: yes/no
baseline
Diabetes
Tidsramme: baseline
categorical variable (depending on the type of diabetes: 1 or 2).
baseline
Dyslipidemias
Tidsramme: baseline
qualitative variables: hypercholesterolemia / hyper triglyceridemia
baseline
Medical treatments for dyslipidemia
Tidsramme: baseline
depending on the type of medication: statins, fibrates, other
baseline
Metabolic syndrome
Tidsramme: baseline
binary variable: present / absent
baseline
Age of first menstruation
Tidsramme: baseline
quantitative variable in years
baseline
Parity
Tidsramme: baseline
number of children
baseline
breastfeeding
Tidsramme: baseline
binary variable : yes / no
baseline
Menstrual status
Tidsramme: baseline
menopausal status will be treated as a binary variable
baseline
Duration of exposure to different variables
Tidsramme: baseline
quantitative variable in months
baseline
fruits
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline
vegetables
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline
meat
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline
fish
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline
dairy products
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline
fats
Tidsramme: baseline
frequency of intake assessed by a frequency food questionnaire
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

Samarbejdspartnere

National Cancer Institute, France

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. august 2010

Primær færdiggørelse (Faktiske)

14. november 2013

Studieafslutning (Faktiske)

14. november 2013

Datoer for studieregistrering

Først indsendt

31. januar 2019

Først indsendt, der opfyldte QC-kriterier

21. februar 2019

Først opslået (Faktiske)

25. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHUBX 2010/03

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hepatocellulært karcinom

Kliniske forsøg med Blood test and self-administrated questionnaires

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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