NCT03356535

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

November 23, 2017

Last Update Submit

November 23, 2017

Conditions

Hepatocellular Carcinoma

Keywords

targeted metabolomicsmultivariate statisticsmetabolic signaturespartial least squareshealthy lifestyle indexEPIC

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29924298DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2017

First Posted

November 29, 2017

Study Start

August 1, 2015

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11