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临床试验/NCT05934058
NCT05934058尚未招募不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 383,980 人开始时间: 2023年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
383,980
试验地点
1
主要终点
Impact of dietary and lifestyle habits, including infrequent ones on the aetiology of gastric cancer

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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

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

时间窗: 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

次要结局

  • Development of a genome-wide modelling of Polygenic risk score (PRS) in gastric cancer(Through study completition, three years. Blood samples were collected at the diagnosis (cases) or at the enrollment (controls))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Boccia Stefania

Full Professor of Hygiene and Preventive Medicine

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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