Genomic and Dietary Aspects in Gastric Cancer Risk

Gastric Cancer Clinical Trial

— GenoStoP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934058
• Other study ID #: 5523
• Status: Not yet recruiting
• Start date: July 25, 2023
• Est. completion date: July 25, 2027

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefania Boccia, PhD
• Phone: +39 (0) 6 35001527
• Email: stefania.boccia[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 383980
• Est. completion date: July 25, 2027
• Est. primary completion date: January 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Italy	Dipartimento Universitario di Scienze della Vita e Sanità Pubblica	Roma	Italia

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Erratum In: PLoS Genet. 2013 Apr;9(4). doi: 10.1371/annotation/b91ba224-10be-409d-93f4-7423d502cb — View Citation

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, — View Citation

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, — View Citation

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, Bellavi — View Citation

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, Vi — View Citation

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 — View Citation

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 — View Citation

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, In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Development of a genome-wide modelling of Polygenic risk score (PRS) in gastric cancer	Construction and evaluation of a PRS and a prediction model for gastric cancer, and evaluation of the performance in a validation sample	Through study completition, three years. Blood samples were collected at the diagnosis (cases) or at the enrollment (controls)