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NCT Number: NCT05934058

Genomic and Dietary Aspects in Gastric Cancer Risk

Gastric Cancer (GC) ranks fourth in the number of deaths worldwide and it is sixth in Italy with almost 9,000 deaths in 2020. Survival of GC is one of the lowest reported amongst major cancers, thus making prevention a central priority for its control. However there is currently a lack of evidence on gastric cancer determinants.

Our study will pursue the following specific objectives:

* analyze dietary and lifestyle habits for GC, also infrequent ones (WP1); * analyze major risk factors in rare patient subgroups (WP2); * develop a Genome-wide Modelling of polygenic risk score (PRS) in GC (WP3)

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Susceptibility Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Predisposition to Disease Genetic Risk Score Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, 00168, Italy

About this study

The Stomach cancer Pooling project (StoP) Consortium dataset has grown to the current number of 35 studies from Europe, America, Middle East and Eastern Asia. It will be used as the cornerstone upon which the investigation on the dietary and lifestyle determinants of gastric cancer (GC) will be built. It will allow the analyses of relatively infrequent habits or exposures, genetic factors as well as to perform sufficiently powered analyses of interactions and subgroups that may present relevant heterogeneity in the etiological correlates of GC.

The potential of genomics to personalize and thereby improve diagnosis, treatment, and prognosis of individuals has long been recognized, but so far evidence of the opportunity for genomics to drive prevention remains limited. Recent advances in research on Polygenic Risk Score (PRS) have created new interest about the use of genetic information in prevention of common diseases and its application to risk stratification. A long-lasting open question is whether common genetic variants used to build PRS are able to predict the risk of developing complex diseases with enough power to be used in a clinical setting.

The lack of large enough dataset able to allow an unbiased PRS validation, hampered this question to be answered for many years. This study builds upon the StoP project (a consortium collecting data from about 13,500 GC cases and 32,000 controls) and the UK Biobank (480 GC cases and 338,000 controls) to develop a Polygenic Risk Score for gastric cancer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients participating in studies that collaborate with the StoP Project
  • Patient enrolled by the UK Biobank

Exclusion criteria

  • Age <18 years old
  • Studies with less than 80 cases of histologically confirmed Gastric Cancer

Treatment and study plan

Primary outcomes

  1. Impact of dietary and lifestyle habits, including infrequent ones on the aetiology of gastric cancer

    Time frame: The analysis will be completed in three years. Data about lifestyle and dietary habits were collected through a questionnaire at enrollment.

    Analysis of the association of dietary and lifestyle habits (e.g. caroteinoids, allium plant consumption, calcium, sodium intake, pipe and cigar smoking) from survey data with gastric cancer development

  2. Impact of major gastric cancer risk factors on its aetiology in rarer patients subgroups

    Time frame: The analysis will be completed in three years. Data about lifestyle and dietary habits were collected through a questionnaire at enrollment.

    Analysis of the association between major risk factors in subgroups of studies or in rare patient groups (e.g.: gastric cancer in young people, cancer occurring at gastric cancer) and gastric cancer

Secondary outcomes

  1. Development of a genome-wide modelling of Polygenic risk score (PRS) in gastric cancer

    Time frame: Through study completition, three years. Blood samples were collected at the diagnosis (cases) or at the enrollment (controls)

    Construction and evaluation of a PRS and a prediction model for gastric cancer, and evaluation of the performance in a validation sample

Study contacts

Contact information is provided by the study sponsor or research team.

Roberta Pastorino, PhD

CONTACT

[email protected]

+39 (0) 6 30154396

Stefania Boccia, PhD

CONTACT

[email protected]

+39 (0) 6 35001527

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • University of Bologna

Registry information

Official study title

Interaction of Genomic and Dietary Aspects in Gastric Cancer Risk: the Global StoP Project

Acronym: GenoStoP

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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