System Biology of Spleen Deficiency Syndrome

Gastric Cancer Clinical Trial

— SBSDS  

Official title:

System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02915393
• Other study ID #: 81430099
• Status: Not yet recruiting
• Phase: N/A
• First received: September 17, 2016
• Last updated: September 23, 2016
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2016
• Source: Beijing University of Chinese Medicine
• Contact: Xiaopu Sang
• Phone: +86 15101021386
• Email: sxp[@]bucm.edu.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 65 years.

• No apparent abnormality in the routine blood test, urinalysis, routine stool & fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG).

• The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses

• TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome.

• Voluntary participation.

• Having given written informed consent.

Exclusion Criteria:

• Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma).

• Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis).

• Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases.

• Pregnancy, or planning pregnancy during the trial or within three month period thereafter.

• Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gastric Cancer
• Gastritis
• Gastritis, Atrophic
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the stomach with an endoscope.	Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.	at the beginning of the enrollment	Yes
Primary	Pathological biopsy of gastric mucosa.	Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China	at the beginning of the enrollment	Yes
Primary	Detection of helicobacter pylori by Urea Breath Test(UBT)		at the beginning of the enrollment	No
Secondary	Analysis of gastric mucosa/venous blood/urine by system biology techniques		Three measurements within 1 year	No
Secondary	Constitutional classification of TCM assessed by the Traditional Chinese Medicine Physical Constitution Scale		at the beginning of the enrollment	No
Secondary	TCM syndrome type diagnosed by two professional TCM doctors		at the beginning of the enrollment	No