Clinical trial NCT05934058: Genomic and Dietary Aspects in Gastric Cancer Risk
Official title: Interaction of Genomic and Dietary Aspects in Gastric Cancer Risk: the Global StoP Project
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Cancer
Keywords: gastric cancer
StoP Consortium
genomics
dietary aspects
Polygenic Risk Score
gastric cardia carcinoma
gastric neoplasm
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2023-07-06
Enrollment: 383980
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients involved as GC cases or controls in the studies that are collaborating with the StoP project. Cases are primary gastric carcinoma patients, with histological confirmation. Controls are selected from cancer-free patients and matched with the cases.

Patient enrolled by the UK Biobank

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of dietary and lifestyle habits, including infrequent ones on the aetiology of gastric cancer
timeFrame: The analysis will be completed in three years. Data about lifestyle and dietary habits were collected through a questionnaire at enrollment.
measure: Impact of major gastric cancer risk factors on its aetiology in rarer patients subgroups
timeFrame: The analysis will be completed in three years. Data about lifestyle and dietary habits were collected through a questionnaire at enrollment.
Secondary outcomes:
measure: Development of a genome-wide modelling of Polygenic risk score (PRS) in gastric cancer
timeFrame: Through study completition, three years. Blood samples were collected at the diagnosis (cases) or at the enrollment (controls)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
state: Italia
Study officials:
affiliation: IRCCS Fondazione Policlinico Universitario Agostino Gemelli
name: Stefania Boccia, PhD
role: PRINCIPAL_INVESTIGATOR
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