Gastric CancerNCT06134011
A Multi-omics-based Metabolic Typing Study of Gastric Cancer
An observational study of Gastric Cancer and Multi-omics, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
In the study, the investigators obtained gastric cancer tissues from 480 gastric cancer patients who had undergone surgery at the Zhejiang Cancer Hospital's biospecimen bank between 2012-2019, and obtained relevant clinical information. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Multi-omics, Diagnosis
- What is being tested?
- Without any intervention
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2023to 10 Sep 2024
- How long will I take part?
- 10 Years
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: These cases have histologically or cytologically confirmed gastric cancer and there are no other tumors
Who may be able to join
- 18≤age≤80
- Histologically or cytologically confirmed gastric cancer
- Undergo surgery for radical or palliative gastric cancer (both open and laparoscopic)
- Patients with survival follow-up information
Who cannot join
- Two or more kinds of malignant tumors at the same time
- Incomplete or missing case information
- Preoperative diagnosis of residual gastric cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang
About this study
Official title: Clinical Study on Metabolic Typing of Gastric Cancer Based on Transcriptome, Metabolome and Other Multi-omics
In the study, the investigators obtained gastric cancer tissues from 480 gastric cancer patients who had undergone surgery at the Zhejiang Cancer Hospital's biospecimen bank between 2012-2019, and obtained relevant clinical information. The gastric cancer tissues were subjected to transcriptomic, metabolomic and other multi-omics testing, and analyzed for the metabolic changes of gastric cancer, and proposed to discover relevant therapeutic targets.
- Conditions
- Gastric Cancer, Multi-omics, Diagnosis
- Being tested
- Without any intervention
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Without any interventionOther
There were no special interventions for the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Cancer tissues | Not described Receives: Other: Without any intervention | |
| Normal adjacent tissues | Not described Receives: Other: Without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of the metabolism information
The differences of the metabolism information between gastric cancer tissues and non-cancerous gastric cancer tissues. These data included Metabolizing enzyme mRNA expression and metabolite content.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Sep 2023
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Zhejiang Cancer 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
- Case only
- Time perspective
- Other
- Enrolment
- 480 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134011
- Sponsor's protocol ID
- IRB-2023-935
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.
Publications
Li S, Yuan L, Xu ZY, Xu JL, Chen GP, Guan X, Pan GZ, Hu C, Dong J, Du YA, Yang LT, Ni MW, Jiang RB, Zhu X, Lv H, Xu HD, Zhang SJ, Qin JJ, Cheng XD. Integrative proteomic characterization of adenocarcinoma of esophagogastric junction. Nat Commun. 2023 Feb 11;14(1):778. doi: 10.1038/s41467-023-36462-8.
PubMed 36774361Shi W, Wang Y, Xu C, Li Y, Ge S, Bai B, Zhang K, Wang Y, Zheng N, Wang J, Wang S, Ji G, Li J, Nie Y, Liang W, Wu X, Cui J, Wang Y, Chen L, Zhao Q, Shen L, He F, Qin J, Ding C. Multilevel proteomic analyses reveal molecular diversity between diffuse-type and intestinal-type gastric cancer. Nat Commun. 2023 Feb 14;14(1):835. doi: 10.1038/s41467-023-35797-6.
PubMed 36788224Wang J, Kunzke T, Prade VM, Shen J, Buck A, Feuchtinger A, Haffner I, Luber B, Liu DHW, Langer R, Lordick F, Sun N, Walch A. Spatial Metabolomics Identifies Distinct Tumor-Specific Subtypes in Gastric Cancer Patients. Clin Cancer Res. 2022 Jul 1;28(13):2865-2877. doi: 10.1158/1078-0432.CCR-21-4383.
PubMed 35395077
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Metabolic Typing of Gastric Cancer Based on Transcriptome, Metabolome and Other Multi-omics
- ClinicalTrials.gov ID
- NCT06134011
- Acronym / sponsor ID
- IRB-2023-935
- Conditions
- Gastric Cancer, Multi-omics, Diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 18 Nov 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.
In the study, the investigators obtained gastric cancer tissues from 480 gastric cancer patients who had undergone surgery at the Zhejiang Cancer Hospital's biospecimen bank between 2012-2019, and obtained relevant clinical information. The gastric cancer tissues were subjected to transcriptomic, metabolomic and other multi-omics testing, and analyzed for the metabolic changes of gastric cancer, and proposed to discover relevant therapeutic targets.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer tissues | – | Other: Without any intervention |
| Normal adjacent tissues | – | Other: Without any intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- These cases have histologically or cytologically confirmed gastric cancer and there are no other tumors
Key inclusion criteria (4 listed)
- 18≤age≤80
- Histologically or cytologically confirmed gastric cancer
- Undergo surgery for radical or palliative gastric cancer (both open and laparoscopic)
- Patients with survival follow-up information
Key exclusion criteria (3 listed)
- Two or more kinds of malignant tumors at the same time
- Incomplete or missing case information
- Preoperative diagnosis of residual 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Without any interventionThere were no special interventions for the two groups. | Other | Cancer tissues, Normal adjacent tissues |
Primary outcome
The differences of the metabolism information
Time frame: through study completion, an average of 6 months
The differences of the metabolism information between gastric cancer tissues and non-cancerous gastric cancer tissues. These data included Metabolizing enzyme mRNA expression and metabolite content.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 36774361Li S, Yuan L, Xu ZY, Xu JL, Chen GP, Guan X, Pan GZ, Hu C, Dong J, Du YA, Yang LT, Ni MW, Jiang RB, Zhu X, Lv H, Xu HD, Zhang SJ, Qin JJ, Cheng XD. Integrative proteomic characterization of adenocarcinoma of esophagogastric junction. Nat Commun. 2023 Feb 11;14(1):778. doi: 10.1038/s41467-023-36462-8.
- Results publication: PubMed 36788224Shi W, Wang Y, Xu C, Li Y, Ge S, Bai B, Zhang K, Wang Y, Zheng N, Wang J, Wang S, Ji G, Li J, Nie Y, Liang W, Wu X, Cui J, Wang Y, Chen L, Zhao Q, Shen L, He F, Qin J, Ding C. Multilevel proteomic analyses reveal molecular diversity between diffuse-type and intestinal-type gastric cancer. Nat Commun. 2023 Feb 14;14(1):835. doi: 10.1038/s41467-023-35797-6.
- Results publication: PubMed 35395077Wang J, Kunzke T, Prade VM, Shen J, Buck A, Feuchtinger A, Haffner I, Luber B, Liu DHW, Langer R, Lordick F, Sun N, Walch A. Spatial Metabolomics Identifies Distinct Tumor-Specific Subtypes in Gastric Cancer Patients. Clin Cancer Res. 2022 Jul 1;28(13):2865-2877. doi: 10.1158/1078-0432.CCR-21-4383.
- Individual participant dataSharing planned: No. This study does not involve drug clinical trials but focuses on ensuring the confidentiality of patient information. To protect patient privacy, a coding system was used instead of real names when entering patient information such as names and ages. Each patient was assigned a study identification number upon enrollment. Throughout the entire study, only the main researchers in the research team have the authority to access the true personal data of patients obtained from the electronic database (such as names and ages), and it is strictly prohibited to circulate or share this information. During the publication of the research article, the main researchers in the research team will use sample coding to replace patient privacy information (such as names) to achieve de-identification. Additionally, the protection of personal information for study participants must be maintained throughout the entire research process, and it is strictly forbidden to circulate or leak such information.
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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 and Multi-omics, run by Zhejiang Cancer 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 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 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?
Results are not available in the source record.
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 differences of the metabolism information (time frame: through study completion, an average of 6 months). 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 NCT06134011, which also lists 3 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 18 Nov 2023.