Metabolic Signature of Healthy Lifestyle and HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-09-15

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hepatocellular Carcinoma

Keywords

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targeted metabolomics multivariate statistics metabolic signatures partial least squares healthy lifestyle index EPIC

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

References

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Assi N, Gunter MJ, Thomas DC, Leitzmann M, Stepien M, Chajes V, Philip T, Vineis P, Bamia C, Boutron-Ruault MC, Sandanger TM, Molinuevo A, Boshuizen H, Sundkvist A, Kuhn T, Travis R, Overvad K, Riboli E, Scalbert A, Jenab M, Viallon V, Ferrari P. Metabolic signature of healthy lifestyle and its relation with risk of hepatocellular carcinoma in a large European cohort. Am J Clin Nutr. 2018 Jul 1;108(1):117-126. doi: 10.1093/ajcn/nqy074.

Reference Type DERIVED

PMID: 29924298 (View on PubMed)

Other Identifiers

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PP201711-27

Identifier Type: -

Identifier Source: org_study_id

Metabolic Signature of Healthy Lifestyle and HCC

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Sponsors

Imperial College London

Danish Cancer Society

University of Aarhus

Centre for Research in Epidemiology and Population Health (CESP)

Gustave Roussy, Cancer Campus, Grand Paris

German Cancer Research Center

German Institute of Human Nutrition

Hellenic Health Foundation

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

ISPO Cancer Prevention and Research Institute

Federico II University

HuGeF Foundation

Azienda Sanitaria Provinciale Ragusa

University of Tromso

Institut Català d'Oncologia

Ministry of Health - Government of the Principality of Asturias

Andalusian School of Public Health

Universidad de Murcia

Instituto de Salud Pública Gobierno de Navarra

Subdirección de Salud Pública de Gipuzkoa

Skane University Hospital

Umeå University

MORGEN-EPIC, Bilthoven

Prospect-EPIC, Utrecht

University of Oxford

University of Cambridge

International Agency for Research on Cancer

Responsible Party

References

Other Identifiers

PP201711-27