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

Sponsor
Xijing Hospital of Digestive Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT06031779
Collaborator
(none)
1,000
Enrollment
1
Location
14
Anticipated Duration (Months)
71.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Application of Serum Bile Acid Profile in the Diagnosis of Gastric Cancer
    Actual Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    gastric cancer
    non-gastric cancer

    Outcome Measures

    Primary Outcome Measures

    1. serum bile acid profile before treatment [1 month]

    Secondary Outcome Measures

    1. concentration of serum tumor markers before treatment [1 month]

      CEA, CA19-9 and CA12-5

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hosipital of Digestive Disease Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital of Digestive Diseases

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongquan Shi, Principal Investigator,Clinical Professor, Xijing Hospital of Digestive Diseases
    ClinicalTrials.gov Identifier:
    NCT06031779
    Other Study ID Numbers:
    • KY20232258-C-1
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 13, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yongquan Shi, Principal Investigator,Clinical Professor, Xijing Hospital of Digestive Diseases
    serum bile acid
    biomarker
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Sep 13, 2023