Genomic and Dietary Aspects in Gastric Cancer Risk

NCT05934058 | Not Yet Recruiting DMC

• 1 other identifier: 5523
• Study Type: observational
• Target: 383,980
• Locations: 1 country
• Sites: 1

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)

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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

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

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

  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

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

Secondary Outcomes (1)

• 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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• University of Bologna: collaborator

Study Sites (1)

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, 00168, Italy

Location

Related Publications (10)

• Pelucchi C, Lunet N, Boccia S, Zhang ZF, Praud D, Boffetta P, Levi F, Matsuo K, Ito H, Hu J, Johnson KC, Ferraroni M, Yu GP, Peleteiro B, Malekzadeh R, Derakhshan MH, Ye W, Zaridze D, Maximovitch D, Aragones N, Martin V, Pakseresht M, Pourfarzi F, Bellavia A, Orsini N, Wolk A, Mu L, Arzani D, Kurtz RC, Lagiou P, Trichopoulos D, Muscat J, La Vecchia C, Negri E. The stomach cancer pooling (StoP) project: study design and presentation. Eur J Cancer Prev. 2015 Jan;24(1):16-23. doi: 10.1097/CEJ.0000000000000017.

  PMID: 24566154 RESULT

• Rota M, Pelucchi C, Bertuccio P, Matsuo K, Zhang ZF, Ito H, Hu J, Johnson KC, Palli D, Ferraroni M, Yu GP, Muscat J, Lunet N, Peleteiro B, Ye W, Song H, Zaridze D, Maximovitch D, Guevara M, Fernandez-Villa T, Vioque J, Navarrete-Munoz EM, Wolk A, Orsini N, Bellavia A, Hakansson N, Mu L, Persiani R, Kurtz RC, Lagiou A, Lagiou P, Galeone C, Bonzi R, Boffetta P, Boccia S, Negri E, La Vecchia C. Alcohol consumption and gastric cancer risk-A pooled analysis within the StoP project consortium. Int J Cancer. 2017 Nov 15;141(10):1950-1962. doi: 10.1002/ijc.30891. Epub 2017 Aug 8.

  PMID: 28718913 RESULT

• Praud D, Rota M, Pelucchi C, Bertuccio P, Rosso T, Galeone C, Zhang ZF, Matsuo K, Ito H, Hu J, Johnson KC, Yu GP, Palli D, Ferraroni M, Muscat J, Lunet N, Peleteiro B, Malekzadeh R, Ye W, Song H, Zaridze D, Maximovitch D, Aragones N, Castano-Vinyals G, Vioque J, Navarrete-Munoz EM, Pakseresht M, Pourfarzi F, Wolk A, Orsini N, Bellavia A, Hakansson N, Mu L, Pastorino R, Kurtz RC, Derakhshan MH, Lagiou A, Lagiou P, Boffetta P, Boccia S, Negri E, La Vecchia C. Cigarette smoking and gastric cancer in the Stomach Cancer Pooling (StoP) Project. Eur J Cancer Prev. 2018 Mar;27(2):124-133. doi: 10.1097/CEJ.0000000000000290.

  PMID: 27560662 RESULT

• Ferro A, Rosato V, Rota M, Costa AR, Morais S, Pelucchi C, Johnson KC, Hu J, Palli D, Ferraroni M, Zhang ZF, Bonzi R, Yu GP, Peleteiro B, Lopez-Carrillo L, Tsugane S, Hamada GS, Hidaka A, Zaridze D, Maximovitch D, Vioque J, Navarrete-Munoz EM, Aragones N, Martin V, Hernandez-Ramirez RU, Bertuccio P, Ward MH, Malekzadeh R, Pourfarzi F, Mu L, Lopez-Cervantes M, Persiani R, Kurtz RC, Lagiou A, Lagiou P, Boffetta P, Boccia S, Negri E, Camargo MC, Curado MP, La Vecchia C, Lunet N. Meat intake and risk of gastric cancer in the Stomach cancer Pooling (StoP) project. Int J Cancer. 2020 Jul 1;147(1):45-55. doi: 10.1002/ijc.32707. Epub 2019 Nov 22.

  PMID: 31584199 RESULT

• DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2.

  PMID: 3802833 RESULT

• Jin G, Lv J, Yang M, Wang M, Zhu M, Wang T, Yan C, Yu C, Ding Y, Li G, Ren C, Ni J, Zhang R, Guo Y, Bian Z, Zheng Y, Zhang N, Jiang Y, Chen J, Wang Y, Xu D, Zheng H, Yang L, Chen Y, Walters R, Millwood IY, Dai J, Ma H, Chen K, Chen Z, Hu Z, Wei Q, Shen H, Li L. Genetic risk, incident gastric cancer, and healthy lifestyle: a meta-analysis of genome-wide association studies and prospective cohort study. Lancet Oncol. 2020 Oct;21(10):1378-1386. doi: 10.1016/S1470-2045(20)30460-5.

  PMID: 33002439 RESULT

• Qiu L, Qu X, He J, Cheng L, Zhang R, Sun M, Yang Y, Wang J, Wang M, Zhu X, Guo W. Predictive model for risk of gastric cancer using genetic variants from genome-wide association studies and high-evidence meta-analysis. Cancer Med. 2020 Oct;9(19):7310-7316. doi: 10.1002/cam4.3354. Epub 2020 Aug 10.

  PMID: 32777176 RESULT

• Tanikawa C, Kamatani Y, Toyoshima O, Sakamoto H, Ito H, Takahashi A, Momozawa Y, Hirata M, Fuse N, Takai-Igarashi T, Shimizu A, Sasaki M, Yamaji T, Sawada N, Iwasaki M, Tsugane S, Naito M, Hishida A, Wakai K, Furusyo N, Murakami Y, Nakamura Y, Imoto I, Inazawa J, Oze I, Sato N, Tanioka F, Sugimura H, Hirose H, Yoshida T, Matsuo K, Kubo M, Matsuda K. Genome-wide association study identifies gastric cancer susceptibility loci at 12q24.11-12 and 20q11.21. Cancer Sci. 2018 Dec;109(12):4015-4024. doi: 10.1111/cas.13815. Epub 2018 Oct 31.

  PMID: 30281874 RESULT

• Choi J, Jia G, Wen W, Long J, Zheng W. Evaluating polygenic risk scores in assessing risk of nine solid and hematologic cancers in European descendants. Int J Cancer. 2020 Dec 15;147(12):3416-3423. doi: 10.1002/ijc.33176. Epub 2020 Jul 9.

  PMID: 32588423 RESULT

• Dudbridge F. Power and predictive accuracy of polygenic risk scores. PLoS Genet. 2013 Mar;9(3):e1003348. doi: 10.1371/journal.pgen.1003348. Epub 2013 Mar 21.

  PMID: 23555274 RESULT

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

MeSH Terms

Conditions

Stomach Neoplasms; Genetic Risk Score

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefania Boccia, PhD

  IRCCS Fondazione Policlinico Universitario Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Boccia, PhD

CONTACT

+39 (0) 6 35001527; stefania.boccia@policlinicogemelli.it

Roberta Pastorino, PhD

CONTACT

+39 (0) 6 30154396; roberta.pastorino@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Hygiene and Preventive Medicine

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 6, 2023
• Study Start: July 25, 2023
• Primary Completion: January 25, 2025
• Study Completion (Estimated): July 25, 2027
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

IT (1)