Gastric Cardia CancerNCT06702891
Integrative Analysis of Exosome-Mediated Single-Cell Transcriptomics and Proteomics in Gastric Cardia Cancer
An observational study of Gastric Cardia Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cardia Cancer
- What is being tested?
- Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2024to Oct 2027
- How long will I take part?
- 2 Years
- 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: Case: The population in the case group signed an informed consent form, aged 18 years old or older. All subjects underwent endoscopic examination and were confirmed by pathological diagnosis as gastric cancer, including high-grade intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer. Control: The age and gender of the study subjects in the control group were matched to the study population in the case group. The pathological results of the stomach of all subjects showed no malignant changes, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc.
Who may be able to join
- Study population signing informed consent form
- Age: 18 years old or older
- The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.
Who cannot join
- Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.
- Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.
- People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
xiaoyawang99@163.com
About this study
This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as serum and tissue tissue from the study subjects. The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer, and provide a basis for the development of new diagnostic tools and therapeutic strategies.
- Conditions
- Gastric Cardia Cancer
- Being tested
- Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing
- Keywords
- Gastric Cardia Cancer, Single-Cell RNA Sequencing, Exosomes, Proteomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencingOther
The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer.
| Study group | Role | What they receive |
|---|---|---|
| case group | The case group includes high-grade intraepithelial neoplasia of the stomach, early gastric cancer, and advanced gastric cancer. Receives: Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing | |
| control group | Pathological findings in the control group showed no malignant changes in the stomach, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc. Receives: Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential protein
Measured: 6 months
Secondary outcomes (2)
Key miRNA
Measured: 10 months
Differential cell subsets
Differential cell subsets between cardiac cancer tissue and normal tissue
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start17 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cardia 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702891
- Sponsor's protocol ID
- 2024SDU-QILU-2
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Analysis of Exosome-Mediated Single-Cell Transcriptomics and Proteomics in Gastric Cardia Cancer
- ClinicalTrials.gov ID
- NCT06702891
- Acronym / sponsor ID
- 2024SDU-QILU-2
- Conditions
- Gastric Cardia Cancer
- Keywords
- Gastric Cardia Cancer, Single-Cell RNA Sequencing, Exosomes, Proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Nov 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.
This is an observational study with a case control design. This study included patients with gastric cancer confirmed by pathological diagnosis of gastric tissue, and matched the control population according to age, gender, etc. In this study, researchers collected clinical information and multiple biological samples such as serum and tissue tissue from the study subjects. The researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer, and provide a basis for the development of new diagnostic tools and therapeutic strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencingThe case group includes high-grade intraepithelial neoplasia of the stomach, early gastric cancer, and advanced gastric cancer. |
| control group | – | Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencingPathological findings in the control group showed no malignant changes in the stomach, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case: The population in the case group signed an informed consent form, aged 18 years old or older. All subjects underwent endoscopic examination and were confirmed by pathological diagnosis as gastric cancer, including high-grade intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer. Control: The age and gender of the study subjects in the control group were matched to the study population in the case group. The pathological results of the stomach of all subjects showed no malignant changes, including normal gastric mucosa, superficial gastritis, non atrophic gastritis, and gastric polyps, etc.
Key inclusion criteria (3 listed)
- Study population signing informed consent form
- Age: 18 years old or older
- The study population must underwent endoscopic examination and was confirmed by pathological diagnosis as gastric cancer: including high-level intraepithelial neoplasia, early gastric cancer, and advanced gastric cancer.
Key exclusion criteria (3 listed)
- Those who have undergone gastrointestinal surgery within the past 1 year; Patients who have undergone neoadjuvant chemotherapy and have developed tumors in the residual stomach after previous partial gastrectomy.
- Those who have used proton pump inhibitors, antibiotics, probiotics, and prebiotics daily within the past month, and those who have recently received hormone therapy.
- People with infectious diseases and other digestive system diseases that interfere with the experimental results, such as inflammatory bowel disease, irritable bowel syndrome, etc.
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 |
|---|---|---|
| Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencingThe researchers combined exosome sequencing, proteomics and single-cell RNA sequencing to explore the heterogeneity of cardia cancer, identify specific biomarkers and potential therapeutic targets for cardia cancer. | Other | case group, control group |
Primary outcome
Differential protein
Time frame: 6 months
2 secondary outcomes
Key miRNA
Time frame: 10 months
Differential cell subsets
Time frame: 12 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 3 Sep 2026.
Related trials for Gastric Cardia Cancer
Active, not recruitingPhase 2
Proton Beam Therapy (PBT) Versus Intensity-Modulated Radiation Therapy (IMRT) Trial
Esophageal Cancer
RecruitingPhase 2
Timing of Comprehensive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma
Esophageal Cancer, Gastric (Stomach) Cancer
RecruitingObservational study
Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics
Stomach Neoplasm
Active, not recruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers
Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
RecruitingPhase 1
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Esophageal and/or Cardia Cancer, Melanoma
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.
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 Cardia Cancer, run by Qilu Hospital of Shandong University 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 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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?
Contact Xiaoya Wang, Bachelor ((86)13821379210, xiaoyawang99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential protein (time frame: 6 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 Sep 2026.