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

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ClinicalTrials.gov Identifier: NCT06031779
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

Study Description
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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
Gastric Cancer

Study Design
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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort
gastric cancer
non-gastric cancer


Outcome Measures
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Primary Outcome Measures :
  1. serum bile acid profile before treatment [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. concentration of serum tumor markers before treatment [ Time Frame: 1 month ]
    CEA, CA19-9 and CA12-5


Biospecimen Retention:   Samples With DNA
serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients attending Xijing Hospital and Patients included in the biospecimen bank
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031779


Contacts
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Contact: Nuo Yao +86 15319121701 785356949@qq.com
Contact: Yongquan Shi, PhD 86-029-84771515 shiyquan@fmmu.edu.cn

Locations
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China, Shaanxi
Xijing Hosipital of Digestive Disease Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yongquan Shi, PhD    86-029-84771515    shiyquan@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
Investigators
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Study Director: Yongquan Shi, PhD Xijing Hpsipital of Digestive Disease
More Information
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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: September 11, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yongquan Shi, Xijing Hospital of Digestive Diseases:
serum bile acid
biomarker
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases