Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

NCT03314038 | Unknown

• 1 other identifier: 81630080-CAG-CS
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (GC). The present study aims to explore Traditional Chinese Medicine (TCM) syndrome features in different stages of CAG malignant transformation respectively. The proposed study is a cross-sectional study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 study patients will be recruited on-site in hospitals.

Conditions

TCM Syndrome of Chronic Atrophic Gastritis

Keywords

Chronic Atrophic Gastritis; Malignant Transformation; Syndrome; Traditional Chinese Medicine; Cross-sectional Study

Outcome Measures

Primary Outcomes (1)

• TCM syndrome

  According to the symptoms and physical signs of patients to determine the syndrome

  one time at involvement (1 day)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multicenter cross-sectional study conducted in 4 hopitals in Beijing, China,lleaded by Beijing University of Chinese Medicine. According to the inclusion and exclusion criteria, 2000 eligible participants will be involved in this study.

You may qualify if:

• (1) 18-75 years of age; (2) Meeting diagnostic criteria of CAG after upper gastrointestinal endoscopy; (3) Willing to cooperate with data, tissue sample, and blood sample collection during recruitment; (4) Willing to respond truthfully and timely to researcher queries after recruitment, able to cooperate with data, tissue sample and blood sample collection during follow-ups; (5) Willing to sign informed consent.

You may not qualify if:

• (1) Meeting past history of previous stomach surgery; (2) Unable to participate in data, tissue sample or blood sample collection for any reason.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead
• The University of Science and Technology of China: collaborator
• China Academy of Chinese Medical Sciences: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

• Zhang Y, Liu Y, Song R, Zhang L, Su Z, Li Y, Chen R, Shi N, Zhao X, Du S, Ding X. Validating traditional Chinese syndrome features in varied stages of chronic gastritis malignant transformation: study protocol for a cross-sectional study. BMJ Open. 2018 Aug 30;8(8):e020939. doi: 10.1136/bmjopen-2017-020939.

  PMID: 30166291 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and gastric mocusa tissue sample

MeSH Terms

Conditions

Gastritis, Atrophic; Syndrome

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xia Ding, MD

  Beijing University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yin Zhang, MD

CONTACT

coolzhangyin@sina.com

Xia Ding, MD

CONTACT

dingx@bucm.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2017
• First Posted: October 19, 2017
• Study Start: January 1, 2014
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

CN (1)