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Genomic and Dietary Aspects in Gastric Cancer Risk (GenoStoP)

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ClinicalTrials.gov Identifier: NCT05934058
Recruitment Status : Not yet recruiting
First Posted : July 6, 2023
Last Update Posted : July 6, 2023
Sponsor:
Collaborator:
University of Bologna
Information provided by (Responsible Party):
Boccia Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description
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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)

Condition or disease
Gastric Cancer

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 383980 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Interaction of Genomic and Dietary Aspects in Gastric Cancer Risk: the Global StoP Project
Estimated Study Start Date : July 25, 2023
Estimated Primary Completion Date : January 25, 2025
Estimated Study Completion Date : July 25, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort
StoP Consortium + UK Biobank

In the PRS development 338,480 cases and controls from the UK Biobank + 3,650 cases and controls from the StoP consortium studies are going to be enrolled.

Cases are defined as primary gastric carcinoma patients, with histological confirmation.

Controls are selected from cancer-free patients matched with the cases.
StoP Consortium

In the analysis on the aetiology of Gastric Cancer 13,500 cases and 32,000 controls from the StoP consortium studies will be enrolled.

Cases are defined as primary gastric carcinoma patients, with histological confirmation.

Controls are selected from cancer-free patients matched with the cases.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA

The study as a whole recruits a grand total of 383,980 participants but only genetic data from 342,130 individuals will be used.

This number can be further subdivided in:

  • 3,650 participants enrolled in the Stomach Cancer Pooling Project (http://stop-project.org/) These biological samples will be processed to extract DNA data.
  • 338,480 participants enrolled by the UK Biobank. These sample have already been processed. Informatized data from the biomarker samples will be used during the polygenic risk score development. For previously published details of UK Biobank, with anonymized data made available for researchers, please see: https://www.ukbiobank.ac.uk/enable-your-research/about-our-data/biomarker-data

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05934058


Contacts
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Contact: Stefania Boccia, PhD +39 (0) 6 35001527 stefania.boccia@policlinicogemelli.it
Contact: Roberta Pastorino, PhD +39 (0) 6 30154396 roberta.pastorino@policlinicogemelli.it

Locations
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Italy
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, Italy, 00168
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
University of Bologna
Investigators
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Principal Investigator: Stefania Boccia, PhD IRCCS Fondazione Policlinico Universitario Agostino Gemelli
More Information
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Publications of Results:

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Responsible Party: Boccia Stefania, Full Professor of Hygiene and Preventive Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05934058    
Other Study ID Numbers: 5523
First Posted: July 6, 2023    Key Record Dates
Last Update Posted: July 6, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boccia Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
gastric cancer
StoP Consortium
genomics
dietary aspects
 Polygenic Risk Score
gastric cardia carcinoma
gastric neoplasm
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases