Metabolic Signature of Healthy Lifestyle and HCC

November 23, 2017 updated by: International Agency for Research on Cancer

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

294

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Over 520,000 healthy men and women aged 25-85 were enrolled between 1992 and 2000 across 23 EPIC administrative centres in 10 European countries including Denmark, France, Germany, Greece, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom.

This analysis focused on a nested case-control study of 147 cases of HCC and 147 matched controls with available biological samples.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatocellular Carcinoma
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Agency for Research on Cancer

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 15, 2017

Study Completion (Actual)

September 15, 2017

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP201711-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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