Metabolic Signature of Healthy Lifestyle and HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Metabolic Signature of Healthy Lifestyle and Its Relationship With Risk of Hepatocellular Carcinoma in a Large European Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03356535
• Other study ID #: PP201711-27
• Status: Completed
• Phase: N/A
• First received: November 23, 2017
• Last updated: November 23, 2017
• Start date: August 1, 2015
• Est. completion date: September 15, 2017

Study information

• Verified date: November 2017
• Source: International Agency for Research on Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and its incidence is increasing including in regions where hepatitis infection rates are low. This trend may be the result of increases in 'unhealthy lifestyle' factors. The main aim of this study is to identify metabolic signatures associated with healthy lifestyle behaviours and to relate these signatures to risk of developing HCC to investigate whether the metabolites were of predictive utility for HCC beyond data procured from questionnaires. To address this question, we exploited data from a large European cohort (EPIC) which includes detailed questionnaire-based data as well as metabolomic data.

Description:

Studies using metabolomic data have identified metabolites from several compound classes that are associated with disease-related lifestyle factors. This study identified metabolic signatures reflecting lifestyle patterns and related them to hepatocellular carcinoma (HCC) risk in the EPIC cohort. Partial Least Squares (PLS) analysis related seven modified Healthy Lifestyle Index variables (diet, BMI, physical activity, lifetime alcohol, smoking, diabetes, hepatitis) to 132 targeted serum-measured metabolites, and a liver function score in a nested study of HCC with 147 case-control pairs. The association between the resulting PLS scores and HCC risk was examined in multivariable conditional logistic regression models where odds ratios (OR) and their 95% confidence intervals (95%CI) were computed. The PLS-derived lifestyle component reflected a high propensity towards healthy behaviours. Its metabolic counterpart was positively related to the following metabolites: SM(OH) C14:1, C16:1 and C22:2, and negatively to glutamate, hexoses, and PC aaC32:1. The lifestyle and metabolomics components were inversely associated with HCC risk with OR for a 1-SD increase in scores equal to 0.49(95%CI=0.35 to 0.68) and 0.28(0.18 to 0.43).

Measuring a specific metabolites panel may identify strata of the population at higher risk for HCC and can add substantial discrimination compared to questionnaire data

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 30-70

• Healthy volunteers residing within defined geographical areas (where study centers are located). Different settings by centre; mostly general population with some exceptions: women of a health insurance company for teachers and school workers (France), women attending breast cancer screening (Utrecht-The Netherlands, and Florence-Italy), mainly blood donors (most centers in Italy and Spain) and a cohort consisting predominantly of vegetarians (the 'health-conscious' group in Oxford, UK)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (27)

Lead Sponsor

Collaborator

International Agency for Research on Cancer

Andalusian School of Public Health, Azienda Sanitaria Provinciale Ragusa, Catalan Institute of Oncology, Barcelona, Centre for Research in Epidemiology and Population Health (CESP), Consejería de Sanidad del Principado de Asturias, Danish Cancer Society, Federico II University, Fondazione IRCCS Istituto Nazionale dei Tumori, German Cancer Research Center, German Institute of Human Nutrition, Gustave Roussy, Cancer Campus, Grand Paris, Hellenic Health Foundation, HuGeF Foundation, Imperial College London, Instituto de Salud Pública Gobierno de Navarra, ISPO Cancer Prevention and Research Institute, MORGEN-EPIC, Bilthoven, Prospect-EPIC, Utrecht, Skane University Hospital, Subdirección de Salud Pública de Gipuzkoa, Umeå University, Universidad de Murcia, University of Aarhus, University of Cambridge, University of Oxford, University of Tromso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatocellular Carcinoma	Incident HCC cases were defined as first primary invasive tumours and identified through the 10th Revision of International Statistical Classification of Diseases, Injury and Causes of Death (ICD10) as C22.0 with morphology codes ICD-O-2 "8170/3"and "8180/3"	Follow-up started at date of entry to the study and finished at date of diagnosis, death or last completed follow-up (from December 2004 up to June 2010). Cancer incidence was determined through population cancer registries or through active follow-up.