Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer

July 1, 2025 updated by: Yongquan Shi, Xijing Hospital of Digestive Diseases
In this study, the composition and level of serum bile acids in patients with gastric cancer and non-gastric cancer were analyzed by detecting the serum bile acid profile, so as to develop new serological diagnostic methods for early diagnosis and treatment of gastric cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hosipital of Digestive Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients attending Xijing Hospital and Patients included in the biospecimen bank

Description

Inclusion Criteria:

  1. Age between 18-70, both gender;
  2. The gastric cancer group was early gastric cancer or advanced gastric cancer diagnosed by endoscopic examination and pathological biopsy. The non-gastric cancer group included patients without gastric lesions, superficial gastritis, chronic atrophic gastritis, intestinal metaplasia or dysplasia diagnosed by gastroscopy or pathological biopsy;
  3. Informed consent was obtained.

Exclusion Criteria:

  1. The patients have diseases that affect bile acid metabolism, such as liver cirrhosis, gallstones or inflammatory bowel disease, Behcet's disease, etc;
  2. Due to other diseases, the patient took drugs affecting bile acid metabolism, such as cholestyramine, anti-inflammatory Lidan tablets, Danshu capsules, ursodeoxycholic acid, obticholic acid, Schisandrin B, tanshinone ⅡA, Yinzhihuang, etc;
  3. Pregnant women;
  4. Primary tumors of other systems were diagnosed;
  5. Those with poor physiopathological conditions, such as chronic kidney disease requiring long-term dialysis;
  6. Patients with mental illness;
  7. Patients who have received radiotherapy or surgery previously;
  8. Those with poor adherence or difficult to follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
gastric cancer
non-gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum bile acid profile before treatment
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of serum tumor markers before treatment
Time Frame: 1 month
CEA, CA19-9 and CA12-5
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Study Director: Yongquan Shi, PhD, Xijing Hpsipital of Digestive Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

September 3, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232258-C-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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