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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031779
• Other study ID #: KY20232258-C-1
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: Nuo Yao
• Phone: +86 15319121701
• Email: 785356949[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ?A, 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum bile acid profile before treatment		1 month
Secondary	concentration of serum tumor markers before treatment	CEA, CA19-9 and CA12-5	1 month