Risk Factors of Hepatocellular Carcinomas Developed on Non-fibrotic Liver: Case-control Study (NoFlic Study) (NoFlic)
21 februari 2019 uppdaterad 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
283
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Amiens, Frankrike
- CHU Amiens
-
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
-
Villejuif, Frankrike
- CHU Villejuif
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
exposure to Viral hepatitis B
Tidsram: Baseline
|
binary yes / undiagnosed by positive serology for anti-HBc antibodies isolated or associated with positive serology for anti-HBs antibodies
|
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
exposure to viral hepatitis C
Tidsram: baseline
|
binary yes / undiagnosed by positive serology for positive anti-HCV antibodies
|
baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
exposure to Alcohol
Tidsram: baseline
|
binary variable, separating large consumers from others
|
baseline
|
|
exposure to Exogenous female hormones
Tidsram: baseline
|
oral contraceptive coded as a binary variable
|
baseline
|
|
history of liver pathology
Tidsram: baseline
|
binary variable: yes/no
|
baseline
|
|
Family history of liver cancer
Tidsram: baseline
|
binary variable: yes/no
|
baseline
|
|
Diabetes
Tidsram: baseline
|
categorical variable (depending on the type of diabetes: 1 or 2).
|
baseline
|
|
Dyslipidemias
Tidsram: baseline
|
qualitative variables: hypercholesterolemia / hyper triglyceridemia
|
baseline
|
|
Medical treatments for dyslipidemia
Tidsram: baseline
|
depending on the type of medication: statins, fibrates, other
|
baseline
|
|
Metabolic syndrome
Tidsram: baseline
|
binary variable: present / absent
|
baseline
|
|
Age of first menstruation
Tidsram: baseline
|
quantitative variable in years
|
baseline
|
|
Parity
Tidsram: baseline
|
number of children
|
baseline
|
|
breastfeeding
Tidsram: baseline
|
binary variable : yes / no
|
baseline
|
|
Menstrual status
Tidsram: baseline
|
menopausal status will be treated as a binary variable
|
baseline
|
|
Duration of exposure to different variables
Tidsram: baseline
|
quantitative variable in months
|
baseline
|
|
fruits
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
|
vegetables
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
|
meat
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
|
fish
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
|
dairy products
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
|
fats
Tidsram: baseline
|
frequency of intake assessed by a frequency food questionnaire
|
baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 augusti 2010
Primärt slutförande (Faktisk)
14 november 2013
Avslutad studie (Faktisk)
14 november 2013
Studieregistreringsdatum
Först inskickad
31 januari 2019
Först inskickad som uppfyllde QC-kriterierna
21 februari 2019
Första postat (Faktisk)
25 februari 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 februari 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 februari 2019
Senast verifierad
1 januari 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CHUBX 2010/03
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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