NCT06702891

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Dec 2024Oct 2027

First Submitted

Initial submission to the registry

November 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

December 17, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

November 18, 2024

Last Update Submit

September 2, 2026

Conditions

Keywords

Gastric Cardia CancerSingle-Cell RNA SequencingExosomesProteomics

Outcome Measures

Primary Outcomes (1)

  • Differential protein

    6 months

Secondary Outcomes (2)

  • Key miRNA

    10 months

  • Differential cell subsets

    12 months

Study Arms (2)

case group

The case group includes high-grade intraepithelial neoplasia of the stomach, early gastric cancer, and advanced gastric cancer.

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.

Other: Detection of biological samples based on exosome sequencing, proteomics and single-cell RNA sequencing

Interventions

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.

case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Interventions

Single-Cell Gene Expression Analysis

Intervention Hierarchy (Ancestors)

Single-Cell AnalysisCytological TechniquesInvestigative TechniquesGene Expression ProfilingGenetic Techniques

Central Study Contacts

Xiaoya Wang, Bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 25, 2024

Study Start

December 17, 2024

Primary Completion

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Locations