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NCT Number: NCT05812287

Exploring the Difference Between Gastric Cardia Cancer and Non-cardia Gastric Cancer Based on Multiomics

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 saliva, serum, and feces from the study subjects. We combined 16S rRNA sequencing and metabolomics to explore the differences in microbial and metabolic characteristics between gastric cardia cancer and non-cardia gastric cancer for early screening of gastric cancer.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study population signing informed consent form
  • Age: 18-75 years old
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Detection of biological samples based on multi-omics analysis

Other

In this study, we combined microbiological (16SrRNA) and metabolomic mass spectrometry to study the changes in microbial populations and metabolic profiles of various samples such as feces, serum, and saliva, and screen key differential markers.

Primary outcomes

  1. Early gastric cancer detection rate

    Time frame: 36 months

    This study combines 16SrRNA sequencing and metabolomics to explore the differences in microbiota and metabolites between tumor cohorts and healthy controls, and to assist in screening for early gastric cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Miaomiao Ma, Bachelor

CONTACT

[email protected]

(86)17657686098

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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