Gastric CancerNCT06109805
Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis
An observational study of Gastric Cancer, run by Beijing Friendship Hospital at 4 sites in China.
Trial summary
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. 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?
- Gastric cancer
- How many people
- 1,706 participants
- Where
- 4 sitesChina
- Study dates
- 20 Oct 2023to 18 Feb 2025
- 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: The study population included a range of subjects with gastric and non-gastric cancer, including patients with benign gastric disease and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Who may be able to join
- Confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination.
- Collection of plasma samples prior to surgical treatment.
- Availability of complete clinical data.
Who cannot join
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before surgical treatment.
- Incomplete clinical data.
- Pregnancy status.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Renmin Hospital of Wuhan University
Wuhan
Tongji Hospital, Tongji Medical College of HUST
Wuhan
About this study
Official title: Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.
Read the detailed description
Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information.
Secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy.
Ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.
- Conditions
- Gastric Cancer
- Being tested
- Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric cancerOther
Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer group | Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer Receives: Other: Gastric cancer | |
| Non-gastric cancer group | Patients diagnosed with benign gastric diseases or healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma metabolite content
The outcome will be tested by metabolomics detection technology based on mass spectrometry
Measured: Before receiving treatment for gastric cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start20 Oct 2023
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Li, Beijing Friendship Hospital
- Investigators
- Li Min, Ph.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109805
- Sponsor's protocol ID
- BFHHZML20230010
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics
- ClinicalTrials.gov ID
- NCT06109805
- Acronym / sponsor ID
- BFHHZML20230010
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,706 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 31 Oct 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.
The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.
Detailed description
Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information.
Secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy.
Ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer group | – | Other: Gastric cancerPatients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer |
| Non-gastric cancer group | – | –Patients diagnosed with benign gastric diseases or healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included a range of subjects with gastric and non-gastric cancer, including patients with benign gastric disease and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination.
- Collection of plasma samples prior to surgical treatment.
- Availability of complete clinical data.
Key exclusion criteria (5 listed)
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before surgical treatment.
- Incomplete clinical data.
- Pregnancy status.
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 |
|---|---|---|
| Gastric cancerPatients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer | Other | Gastric cancer group |
Primary outcome
Plasma metabolite content
Time frame: Before receiving treatment for gastric cancer
The outcome will be tested by metabolomics detection technology based on mass spectrometry
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 20 Feb 2025.
- 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.
Li Min, Ph.D. principal investigator
Beijing Friendship Hospital
4 sites 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 Beijing Friendship Hospital at 4 sites 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 5 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Plasma metabolite content (time frame: Before receiving treatment for gastric cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2025.