Gastric CancersNCT06854146
The Effect of Environmental Factors on Gastric Cancer Based on Macrogenome
An observational study of Gastric Cancers and Air Pollution, run by Dong Peng at 1 site in China.
Trial summary
The objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancers, Air Pollution
- What is being tested?
- gastric cancer and healthy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy and 1:1 participants with no history of malignancy were included in the study.
Who may be able to join
- age ≥ 18 years;
- patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy;
- no chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
- willing to participate in the study and sign the informed consent form;
- complete clinical data.
Who cannot join
- concurrent primary malignant tumor other than gastric cancer;
- patients with systemic diseases, such as severe cardiopulmonary;
- insufficiency, that affect the choice of treatment plan;
- not suitable for enrollment 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: Study on the Development and Prognosis of Gastric Cancer Based on Environmental Factors and Macrogenome
The objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and macrogenomic data.
- Conditions
- Gastric Cancers, Air Pollution
- Being tested
- gastric cancer, healthy
- Keywords
- Gastric Cancer, Macrogenome, Environmental Pollution, Air Pollution
- 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 cancerDiagnostic test
patients diagnosed with gastric cancer
healthyDiagnostic test
healthy participants
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer group | patients diagnosed with gastric cancer Receives: Diagnostic Test: gastric cancer | |
| control group | healthy participants Receives: Diagnostic Test: healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Description: Time from diagnosis to death from any cause, measured via medical records and follow-up interviews.
Unit: Months
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
Secondary outcomes (1)
Gut microbiome composition differences assessed by shotgun metagenomic sequencing
Measuring Tool: Shotgun metagenomic sequencing (Illumina NovaSeq 6000). Analysis Parameters: Alpha diversity (Shannon index); Beta diversity (Bray-Curtis dissimilarity); Differential abundance of bacterial species (ANCOM-BC).
Unit: Relative abundance (%) / Diversity indices.
Measured: Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Nov 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (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
- NCT06854146
- Sponsor's protocol ID
- 2024-444-01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Development and Prognosis of Gastric Cancer Based on Environmental Factors and Macrogenome
- ClinicalTrials.gov ID
- NCT06854146
- Acronym / sponsor ID
- 2024-444-01
- Conditions
- Gastric Cancers, Air Pollution
- Keywords
- Gastric Cancer, Macrogenome, Environmental Pollution, Air Pollution
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dong PengUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 3 Mar 2025 (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 objectives of this study were to clarify how environmental factors such as air pollution affect the occurrence and development of gastric cancer; to identify patient-specific macrogenomic markers of gastric cancer; and to investigate the mechanism of gastric cancer development based on environmental factors and macrogenomic data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric cancer group | – | Diagnostic Test: gastric cancerpatients diagnosed with gastric cancer |
| control group | – | Diagnostic Test: healthyhealthy participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy and 1:1 participants with no history of malignancy were included in the study.
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- patients with preoperative diagnosis of gastric cancer confirmed by pathologic biopsy;
- no chemotherapy, radiotherapy, targeted and immunotherapy, etc. before enrollment;
- willing to participate in the study and sign the informed consent form;
- complete clinical data.
Key exclusion criteria (5 listed)
- concurrent primary malignant tumor other than gastric cancer;
- patients with systemic diseases, such as severe cardiopulmonary;
- insufficiency, that affect the choice of treatment plan;
- not suitable for enrollment 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 |
|---|---|---|
| gastric cancerpatients diagnosed with gastric cancer | Diagnostic test | gastric cancer group |
| healthyhealthy participants | Diagnostic test | control group |
Primary outcome
Overall Survival (OS)
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
Description: Time from diagnosis to death from any cause, measured via medical records and follow-up interviews. Unit: Months
1 secondary outcome
Gut microbiome composition differences assessed by shotgun metagenomic sequencing
Time frame: Tissue samples collected intraoperatively, sequencing completed within 1 week post-surgery.
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 3 Mar 2025.
- Individual participant dataSharing planned: No. Data sharing is not permitted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University.
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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 and Air Pollution, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2025. 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?
Overall Survival (OS) (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). 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 3 Mar 2025.