Gastric CancerGenoStoPNCT05934058
Genomic and Dietary Aspects in Gastric Cancer Risk
An observational study of Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 383,980 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2023to 25 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients participating in studies that collaborate with the StoP Project
- Patient enrolled by the UK Biobank
Who cannot join
- Age <18 years old
- Studies with less than 80 cases of histologically confirmed Gastric Cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, 00168
About this study
Official title: Interaction of Genomic and Dietary Aspects in Gastric Cancer Risk: the Global StoP Project
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)
Read the 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.
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, StoP Consortium, genomics, dietary aspects, Polygenic Risk Score, gastric cardia carcinoma, gastric neoplasm
- Medical subject headings
- Stomach Neoplasms, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Construction and evaluation of a PRS and a prediction model for gastric cancer, and evaluation of the performance in a validation sample
Measured: Through study completition, three years. Blood samples were collected at the diagnosis (cases) or at the enrollment (controls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start25 Jul 2023 (estimated)
- Primary completion25 Jan 2025 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 383,980 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Principal investigator, Boccia Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Stefania Boccia, PhD, Principal investigator, IRCCS Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934058
- Sponsor's protocol ID
- 5523
- Acronym
- GenoStoP
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24566154Rota 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.
PubMed 28718913Praud 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.
PubMed 27560662Ferro 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.
PubMed 31584199DerSimonian 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.
PubMed 3802833Jin 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.
PubMed 33002439Qiu 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.
PubMed 32777176Tanikawa 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.
PubMed 30281874Choi 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.
PubMed 32588423Dudbridge 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.
PubMed 23555274
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Genomic and Dietary Aspects in Gastric Cancer Risk: the Global StoP Project
- ClinicalTrials.gov ID
- NCT05934058
- Acronym / sponsor ID
- GenoStoP / 5523
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, StoP Consortium, genomics, dietary aspects, Polygenic Risk Score, gastric cardia carcinoma, gastric neoplasm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 383,980 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 25 Jan 2025 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients participating in studies that collaborate with the StoP Project
- Patient enrolled by the UK Biobank
Key exclusion criteria (2 listed)
- Age <18 years old
- Studies with less than 80 cases of histologically confirmed Gastric Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Results publication: PubMed 24566154Pelucchi 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.
- Results publication: PubMed 28718913Rota 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.
- Results publication: PubMed 27560662Praud 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.
- Results publication: PubMed 31584199Ferro 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.
- Results publication: PubMed 3802833DerSimonian 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.
- Results publication: PubMed 33002439Jin 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.
- Results publication: PubMed 32777176Qiu 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.
- Results publication: PubMed 30281874Tanikawa 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.
- Results publication: PubMed 32588423Choi 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.
- Results publication: PubMed 23555274Dudbridge 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefania Boccia, PhD principal investigator
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefania Boccia, PhD (+39 (0) 6 35001527, stefania.boccia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05934058, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.