Gastric CancersNCT06641700
Predictive Value of Air Pollution and Metabolomics for Gastric Cancer.
An observational study of Gastric Cancers, run by Dong Peng at 1 site in China.
Trial summary
As one of the common malignant tumours worldwide, gastric cancer continues to have a high incidence and mortality rate, especially in Asia. Although a large number of studies have focused on its underlying genetic and lifestyle factors, the specific role of environmental factors in gastric cancer development and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancers
- What is being tested?
- diagnosed with gastric cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2029
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients diagnosed with gastric and undergoing radical surgery for gastric cancer at the study centre may be included in the gastric cancer group.
Who may be able to join
- Diagnosis of gastric cancer confirmed by pathology or cytology;
- aged >18 years;
- not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
Who cannot join
- Patients with systemic diseases such as severe cardiorespiratory insufficiency affecting the choice of treatment regimen;
- inappropriate for enrolment as assessed by the investigator;
- incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The Development and Prognosis of Gastric Cancer Based on Air Pollution and Metabolomics
As one of the common malignant tumours worldwide, gastric cancer continues to have a high incidence and mortality rate, especially in Asia. Although a large number of studies have focused on its underlying genetic and lifestyle factors, the specific role of environmental factors in gastric cancer development and progression has not been fully elucidated. Air pollution, a growing environmental problem, and its major components such as PM2.5, PM10, and NO2 have been shown to be closely associated with the occurrence and development of many chronic diseases. Recent studies have gradually revealed the association between air pollution and certain cancer types (e.g., lung cancer), but its relationship with gastric cancer remains relatively unexplored. Against this background, the application of metabolomics provides new perspectives and methods to study the association between gastric cancer and environmental factors. Metabolomics is capable of systematically analysing the metabolite composition and changes in individuals under different environmental exposures, revealing the potential effects of environmental factors, such as air pollution, on individual metabolic functions. By combining air pollution data and metabolomics analysis, investigators can deeply explore the role of environmental factors in the occurrence, development and prognosis of gastric cancer, and thus provide a scientific basis for the development of prevention and treatment strategies.
Read the detailed description
In this study, clinical data, blood, urine and stool specimens were collected by including patients in the healthy control group and gastric cancer group. The air pollution indicators, metabolomics determination and macro genomic determination were extracted from clinical data, blood and stool respectively. The extracted air pollution, metabolomics and intestinal microbiota data were integrated and analysed. Based on machine learning, a comprehensive model was constructed to screen the key indicators that play a role in the development of gastric cancer and construct a prediction model for gastric cancer development. The aim of this study is to investigate how environmental, metabolic and microbiota factors affect the occurrence and development of gastric cancer. Secondly, metabolic markers specific to gastric cancer patients can also be identified, providing a basis for early diagnosis, early intervention and individualised treatment.
- Conditions
- Gastric Cancers
- Being tested
- diagnosed with gastric cancer
- Keywords
- gastric cancer, environment, air pollution, metabolomics, gut microorganisms
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosed with gastric cancerDiagnostic test
Pathological biopsy confirmed the diagnosis of gastric cancer.
| Study group | Role | What they receive |
|---|---|---|
| the gastric cancer group | Pre-operative gastric cancer diagnosed by pathological biopsy in our clinic. Receives: Diagnostic Test: diagnosed with gastric cancer | |
| the contol group | Adults with no history of malignancy and willing to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative complications
Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.
Measured: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Secondary outcomes (1)
Overall survival
Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
Measured: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancersStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641700
- Sponsor's protocol ID
- 2024-221-02
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Prognosis of Gastric Cancer Based on Air Pollution and Metabolomics
- ClinicalTrials.gov ID
- NCT06641700
- Acronym / sponsor ID
- 2024-221-02
- Conditions
- Gastric Cancers
- Keywords
- gastric cancer, environment, air pollution, metabolomics, gut microorganisms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 15 Oct 2024 (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.
As one of the common malignant tumours worldwide, gastric cancer continues to have a high incidence and mortality rate, especially in Asia. Although a large number of studies have focused on its underlying genetic and lifestyle factors, the specific role of environmental factors in gastric cancer development and progression has not been fully elucidated. Air pollution, a growing environmental problem, and its major components such as PM2.5, PM10, and NO2 have been shown to be closely associated with the occurrence and development of many chronic diseases. Recent studies have gradually revealed the association between air pollution and certain cancer types (e.g., lung cancer), but its relationship with gastric cancer remains relatively unexplored. Against this background, the application of metabolomics provides new perspectives and methods to study the association between gastric cancer and environmental factors. Metabolomics is capable of systematically analysing the metabolite composition and changes in individuals under different environmental exposures, revealing the potential effects of environmental factors, such as air pollution, on individual metabolic functions. By combining air pollution data and metabolomics analysis, investigators can deeply explore the role of environmental factors in the occurrence, development and prognosis of gastric cancer, and thus provide a scientific basis for the development of prevention and treatment strategies.
Detailed description
In this study, clinical data, blood, urine and stool specimens were collected by including patients in the healthy control group and gastric cancer group. The air pollution indicators, metabolomics determination and macro genomic determination were extracted from clinical data, blood and stool respectively. The extracted air pollution, metabolomics and intestinal microbiota data were integrated and analysed. Based on machine learning, a comprehensive model was constructed to screen the key indicators that play a role in the development of gastric cancer and construct a prediction model for gastric cancer development. The aim of this study is to investigate how environmental, metabolic and microbiota factors affect the occurrence and development of gastric cancer. Secondly, metabolic markers specific to gastric cancer patients can also be identified, providing a basis for early diagnosis, early intervention and individualised treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the gastric cancer group | – | Diagnostic Test: diagnosed with gastric cancerPre-operative gastric cancer diagnosed by pathological biopsy in our clinic. |
| the contol group | – | –Adults with no history of malignancy and willing to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with gastric and undergoing radical surgery for gastric cancer at the study centre may be included in the gastric cancer group.
Key inclusion criteria (4 listed)
- Diagnosis of gastric cancer confirmed by pathology or cytology;
- aged >18 years;
- not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
Key exclusion criteria (3 listed)
- Patients with systemic diseases such as severe cardiorespiratory insufficiency affecting the choice of treatment regimen;
- inappropriate for enrolment as assessed by the investigator;
- incomplete clinical data.
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 |
|---|---|---|
| diagnosed with gastric cancerPathological biopsy confirmed the diagnosis of gastric cancer. | Diagnostic test | the gastric cancer group |
Primary outcome
Rate of postoperative complications
Time frame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.
1 secondary outcome
Overall survival
Time frame: From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months
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 16 Oct 2024.
- 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 Gastric Cancers, run by Dong Peng 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2024. 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?
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?
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?
Rate of postoperative complications (time frame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.). 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 16 Oct 2024.