Gastric CancerGCNCT03419663
Systematic Review and Meta-analysis of Cereal or Grain Consumption and Gastric Cancer
An observational study of Gastric Cancer, run by West China Hospital at 1 site in China.
Trial summary
This project involved a systematic literature review of published trials of cereal or grain in relation to the risk of gastric cancer. Data was extracted from the publications on PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and heterogeneity was conducted on the extracted data. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- cereal or grain consumption
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2017to 10 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All individuals, both children and adults, regardless of health status
Who may be able to join
- a case-control studies or a cohort study
- investigate the association between cereal or grain intake and GC occurrence
- report an odds ratio (OR) or relative risk (RR) with corresponding 95% confidence intervals (CI)
- provide sufficient data to estimate OR or RR
Who cannot join
- Non-human studies
- GC mortality-based cohort studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cereal or Grain Consumption and Gastric Cancer Risk: a Systematic Review and Meta-analysis of Observational Studies
This project involved a systematic literature review of published trials of cereal or grain in relation to the risk of gastric cancer. Data was extracted from the publications on PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and heterogeneity was conducted on the extracted data.
Read the detailed description
Investigators searched PubMed, EMBASE, Cochrane Library for studies focusing on cereal or grain in relation to the risk of gastric cancer up to October 2017. Summary odd ratios (OR) and 95% confidence intervals (CI) were calculated by using either random effect models or fixed effect models according to the heterogeneity of included studies. Subgroup analysis, heterogeneity, and publication bias were also performed.
- Conditions
- Gastric Cancer
- Being tested
- cereal or grain consumption
- Keywords
- cereal, whole grain, refined grain, gastric cancer, meta analysis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cereal or grain consumptionDietary supplement
intake of cereal, whole grain, refined grain, and other grain of every day
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer | Not described Receives: Dietary Supplement: cereal or grain consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between overall cereal consumption and gastric cancer occurance
perform a pooled analysis of included studies with OR through STATA 12.0
Measured: up to 2 years
Secondary outcomes (3)
the relationship between whole grain and gastric cancer occurance
perform a subgroup analysis to summarize the related OR through STATA 12.0
Measured: up to 2 years
the relationship between refined grain and gastric cancer occurance
perform a subgroup analysis to summarize the related OR through STATA 12.0
Measured: up to 2 years
the relationship between other grain and gastric cancer occurance
perform a subgroup analysis to summarize the related OR through STATA 12.0
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start12 Sep 2017
- Primary completion20 Dec 2017
- Study completion10 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 West China HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Zhou, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419663
- Acronym
- GC
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Y, Yang J, Du L, Li K, Zhou Y. Association of whole grain, refined grain, and cereal consumption with gastric cancer risk: A meta-analysis of observational studies. Food Sci Nutr. 2018 Nov 11;7(1):256-265. doi: 10.1002/fsn3.878. eCollection 2019 Jan.
PubMed 30680179
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cereal or Grain Consumption and Gastric Cancer Risk: a Systematic Review and Meta-analysis of Observational Studies
- ClinicalTrials.gov ID
- NCT03419663
- Acronym / sponsor ID
- GC
- Conditions
- Gastric Cancer
- Keywords
- cereal, whole grain, refined grain, gastric cancer, meta analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 10 Jan 2018 (actual)
- First posted
- 5 Feb 2018 (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.
This project involved a systematic literature review of published trials of cereal or grain in relation to the risk of gastric cancer. Data was extracted from the publications on PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and heterogeneity was conducted on the extracted data.
Detailed description
Investigators searched PubMed, EMBASE, Cochrane Library for studies focusing on cereal or grain in relation to the risk of gastric cancer up to October 2017. Summary odd ratios (OR) and 95% confidence intervals (CI) were calculated by using either random effect models or fixed effect models according to the heterogeneity of included studies. Subgroup analysis, heterogeneity, and publication bias were also performed.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric cancer | – | Dietary Supplement: cereal or grain consumption |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All individuals, both children and adults, regardless of health status
Key inclusion criteria (4 listed)
- a case-control studies or a cohort study
- investigate the association between cereal or grain intake and GC occurrence
- report an odds ratio (OR) or relative risk (RR) with corresponding 95% confidence intervals (CI)
- provide sufficient data to estimate OR or RR
Key exclusion criteria (2 listed)
- Non-human studies
- GC mortality-based cohort studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cereal or grain consumptionintake of cereal, whole grain, refined grain, and other grain of every day | Dietary supplement | gastric cancer |
Primary outcome
the relationship between overall cereal consumption and gastric cancer occurance
Time frame: up to 2 years
perform a pooled analysis of included studies with OR through STATA 12.0
3 secondary outcomes
the relationship between whole grain and gastric cancer occurance
Time frame: up to 2 years
the relationship between refined grain and gastric cancer occurance
Time frame: up to 2 years
the relationship between other grain and gastric cancer occurance
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 30680179Xu Y, Yang J, Du L, Li K, Zhou Y. Association of whole grain, refined grain, and cereal consumption with gastric cancer risk: A meta-analysis of observational studies. Food Sci Nutr. 2018 Nov 11;7(1):256-265. doi: 10.1002/fsn3.878. eCollection 2019 Jan.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 West China Hospital at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 5 Feb 2018. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the relationship between overall cereal consumption and gastric cancer occurance (time frame: up to 2 years). 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 NCT03419663, which also lists 1 linked publication.
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 5 Feb 2018.