Gastrointestinal Tract CancerNCT03433092
Serum Carotenoids and Risk of Gastrointestinal Tract Cancer: Meta-analysis of Ten Studies
An observational study of Gastrointestinal Tract Cancer, run by Yong Zhou at 1 site in China.
Trial summary
Previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of GIT cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Tract Cancer
- What is being tested?
- serum carotenoids
- How many people
- 40,641 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 28 Dec 2017
- 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
- Child, Adult, Older adult
Study population: The study population include people from primary care clinic or community sample.
Who may be able to join
- The study had both case and control groups
- Serum carotenoids levels, relative risk (RR) or OR and corresponding 95% CI were reported
- Patients in case group were diagnosed with GIT cancer
Who cannot join
- ·Animal studies
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of GIT cancer.
- Conditions
- Gastrointestinal Tract Cancer
- Being tested
- serum carotenoids
- Keywords
- Serum carotenoids, Gastrointestinal tract cancer, Meta-analysis
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum carotenoidsOther
In each study, the serum concentrations of carotenoids were detected by high performance liquid chromatography
| Study group | Role | What they receive |
|---|---|---|
| Jing Huang et. al, 2017 | Not described Receives: Other: serum carotenoids | |
| Max Leenders et. al,2014 | Not described Receives: Other: serum carotenoids | |
| Yusuke Okuyama et. al,2014 | Not described Receives: Other: serum carotenoids | |
| GC Kabat et. al,2012 | Not described Receives: Other: serum carotenoids | |
| Christina Persson et. al,2008 | Not described Receives: Other: serum carotenoids | |
| M Jenab et. al,2006 | Not described Receives: Other: serum carotenoids | |
| Kenji Wakai et. al,2005 | Not described Receives: Other: serum carotenoids | |
| Christian C. Abnet et. al,2003 | Not described Receives: Other: serum carotenoids | |
| N Malila et. al,2002 | Not described Receives: Other: serum carotenoids | |
| G Pappalardo et. al,1997 | Not described Receives: Other: serum carotenoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Tract Cancer Incident Measure
The gastrointestinal tract cancer incident would be recorded during the follow-up years.
Measured: Through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Nov 2017
- Primary completion20 Nov 2017
- Study completion28 Dec 2017
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 Gastrointestinal Tract CancerStudies of the same condition, open and under way.
- 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
- 40,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yong Zhou
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Provincial Science and Technology Support Project (2016SZ0047)
- Responsible party
- Sponsor-investigator, Yong Zhou, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433092
- Sponsor's protocol ID
- 2759067085
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang J, Lu MS, Fang YJ, Xu M, Huang WQ, Pan ZZ, Chen YM, Zhang CX. Serum carotenoids and colorectal cancer risk: A case-control study in Guangdong, China. Mol Nutr Food Res. 2017 Oct;61(10). doi: 10.1002/mnfr.201700267. Epub 2017 Jul 31.
PubMed 28605127
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Carotenoids and Risk of Gastrointestinal Tract Cancer: Meta-analysis of Ten Studies
- ClinicalTrials.gov ID
- NCT03433092
- Acronym / sponsor ID
- 2759067085
- Conditions
- Gastrointestinal Tract Cancer
- Keywords
- Serum carotenoids, Gastrointestinal tract cancer, Meta-analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,641 participants (actual)
- Lead sponsor
- Yong ZhouUniversity, hospital or other
- Collaborators
- Sichuan Provincial Science and Technology Support Project (2016SZ0047)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 14 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.
Previous studies have suggested that serum carotenoids may be associated with risk of gastrointestinal tract cancer (GIT cancer), but the results were inconsistent. Thus, the investigators conducted a meta-analysis to evaluate the associations between serum carotenoids and risk of GIT cancer.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Jing Huang et. al, 2017 | – | Other: serum carotenoids |
| Max Leenders et. al,2014 | – | Other: serum carotenoids |
| Yusuke Okuyama et. al,2014 | – | Other: serum carotenoids |
| GC Kabat et. al,2012 | – | Other: serum carotenoids |
| Christina Persson et. al,2008 | – | Other: serum carotenoids |
| M Jenab et. al,2006 | – | Other: serum carotenoids |
| Kenji Wakai et. al,2005 | – | Other: serum carotenoids |
| Christian C. Abnet et. al,2003 | – | Other: serum carotenoids |
| N Malila et. al,2002 | – | Other: serum carotenoids |
| G Pappalardo et. al,1997 | – | Other: serum carotenoids |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population include people from primary care clinic or community sample.
Key inclusion criteria (3 listed)
- The study had both case and control groups
- Serum carotenoids levels, relative risk (RR) or OR and corresponding 95% CI were reported
- Patients in case group were diagnosed with GIT cancer
Key exclusion criteria (1 listed)
- ·Animal 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 |
|---|---|---|
| serum carotenoidsIn each study, the serum concentrations of carotenoids were detected by high performance liquid chromatography | Other | Christian C. Abnet et. al,2003, Christina Persson et. al,2008, G Pappalardo et. al,1997, GC Kabat et. al,2012, Jing Huang et. al, 2017, Kenji Wakai et. al,2005, M Jenab et. al,2006, Max Leenders et. al,2014, N Malila et. al,2002, Yusuke Okuyama et. al,2014 |
Primary outcome
Gastrointestinal Tract Cancer Incident Measure
Time frame: Through study completion, an average of 5 years.
The gastrointestinal tract cancer incident would be recorded during the follow-up 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 22 Feb 2018.
- Results publication: PubMed 28605127Huang J, Lu MS, Fang YJ, Xu M, Huang WQ, Pan ZZ, Chen YM, Zhang CX. Serum carotenoids and colorectal cancer risk: A case-control study in Guangdong, China. Mol Nutr Food Res. 2017 Oct;61(10). doi: 10.1002/mnfr.201700267. Epub 2017 Jul 31.
- Individual participant dataSharing planned: No
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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 Gastrointestinal Tract Cancer, run by Yong Zhou 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 3 inclusion and 1 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 22 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?
Gastrointestinal Tract Cancer Incident Measure (time frame: Through study completion, an average of 5 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 NCT03433092, 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 22 Feb 2018.