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Genomic and Dietary Aspects in Gastric Cancer Risk

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05934058
Acronym
GenoStoP
Enrollment
383980
Registered
2023-07-06
Start date
2023-07-25
Completion date
2027-07-25
Last updated
2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

gastric cancer, StoP Consortium, genomics, dietary aspects, Polygenic Risk Score, gastric cardia carcinoma, gastric neoplasm

Brief summary

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)

Detailed description

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.

Interventions

None listed

Sponsors

University of Bologna
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of dietary and lifestyle habits, including infrequent ones on the aetiology of gastric cancerThe 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
Impact of major gastric cancer risk factors on its aetiology in rarer patients subgroupsThe 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

MeasureTime frameDescription
Development of a genome-wide modelling of Polygenic risk score (PRS) in gastric cancerThrough 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

Countries

Italy

Contacts

Primary ContactStefania Boccia, PhD
stefania.boccia@policlinicogemelli.it+39 (0) 6 35001527
Backup ContactRoberta Pastorino, PhD
roberta.pastorino@policlinicogemelli.it+39 (0) 6 30154396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026