NCT06031779

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

September 3, 2023

Last Update Submit

July 1, 2025

Conditions

Keywords

serum bile acidbiomarker

Outcome Measures

Primary Outcomes (1)

  • serum bile acid profile before treatment

    1 month

Secondary Outcomes (1)

  • concentration of serum tumor markers before treatment

    1 month

Study Arms (2)

gastric cancer

non-gastric cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending Xijing Hospital and Patients included in the biospecimen bank

You may qualify if:

  • Age between 18-70, both gender;
  • 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;
  • Informed consent was obtained.

You may not qualify if:

  • The patients have diseases that affect bile acid metabolism, such as liver cirrhosis, gallstones or inflammatory bowel disease, Behcet's disease, etc;
  • 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;
  • Pregnant women;
  • Primary tumors of other systems were diagnosed;
  • Those with poor physiopathological conditions, such as chronic kidney disease requiring long-term dialysis;
  • Patients with mental illness;
  • Patients who have received radiotherapy or surgery previously;
  • Those with poor adherence or difficult to follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yongquan Shi, PhD

    Xijing Hpsipital of Digestive Disease

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,Clinical Professor

Study Record Dates

First Submitted

September 3, 2023

First Posted

September 11, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

July 3, 2025

Record last verified: 2025-07

Locations