Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study) (NoFlic)
21. februar 2019 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
283
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Amiens, Frankrike
- CHU Amiens
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Bondy, Frankrike
- AP-HP Jean Verdier
-
Bordeaux, Frankrike
- CHU Bordeaux
-
Caen, Frankrike
- CHU Caen
-
Clamart, Frankrike
- AP-HP Hôpital Antoine Beclere
-
Clichy, Frankrike
- AP-HP Hôpital Beaujon
-
Créteil, Frankrike
- Chi Creteil
-
Grenoble, Frankrike
- Chu Grenoble
-
Lyon, Frankrike
- Hôpital Edouard Herriot
-
Lyon, Frankrike
- Hospices Civiles de Lyon
-
Paris, Frankrike
- Ap-Hp Cochin
-
Paris, Frankrike
- AP-HP Hopital Saint Antoine
-
Paris, Frankrike
- AP-HP Hopital Henri Mondor
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Villejuif, Frankrike
- CHU Villejuif
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
exposure to viral hepatitis C
Tidsramme: baseline
|
binary yes / undiagnosed by positive serology for positive anti-HCV antibodies
|
baseline
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. august 2010
Primær fullføring (Faktiske)
14. november 2013
Studiet fullført (Faktiske)
14. november 2013
Datoer for studieregistrering
Først innsendt
31. januar 2019
Først innsendt som oppfylte QC-kriteriene
21. februar 2019
Først lagt ut (Faktiske)
25. februar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHUBX 2010/03
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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