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Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

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ClinicalTrials.gov Identifier: NCT03314038
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
The University of Science and Technology of China
China Academy of Chinese Medical Sciences
Harvard Medical School
Information provided by (Responsible Party):
Dr. Xia Ding, Beijing University of Chinese Medicine

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.

Condition or disease
TCM Syndrome of Chronic Atrophic Gastritis

Detailed Description:

CAG is acknowledged as the precancerous stage GC. Active treatment of CAG is vital in arresting malignant transformation. Traditional Chinese medicine (TCM) has been widely used in treating CAG and preventing GC in China. To date, few study has been conducted to assess the syndrome features of different stages of CAG malignant transformation combining TCM indicators.

The present study aims to explore TCM syndrome features in different stages of CAG malignant transformation. The proposed study is a registry study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 eligible study patients will berecruited on-site in hospitals.

Comparative analysis of prevalence of presenting TCM features is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Exploratory factor analysis,correspondence analysis, association rule analysis, hierarchical clustering analysis, and complex system entropy clustering analysis will be performed respectively for validating features of syndrome in different stages of CAG malignant transformation.

Previous reports on TCM syndrome features for CAG exist, but no studies have been undertaken base on large-sampled study design and detailed analysis in different stages of CAG malignant transformation respectively.

The outcome of our study has the potential to clerify core TCM pathogenesis of CAG, facilitate early intervention, and promote optimization of treatment strategies of CAG malignant transformation by TCM.


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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validating Features of Traditional Chinese Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation: A Cross-sectional Study
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018



Primary Outcome Measures :
  1. TCM syndrome [ Time Frame: one time at involvement (1 day) ]

Biospecimen Retention:   Samples With DNA
Blood and gastric mocusa tissue sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

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

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): NCT03314038


Contacts
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Contact: Yin Zhang, MD coolzhangyin@sina.com
Contact: Xia Ding, MD dingx@bucm.edu.cn

Locations
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China, Beijing
Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100029
Contact: Xia Ding, MD       dingx@bucm.edu.cn   
Sponsors and Collaborators
Beijing University of Chinese Medicine
The University of Science and Technology of China
China Academy of Chinese Medical Sciences
Harvard Medical School
Investigators
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Principal Investigator: Xia Ding, MD Beijing University of Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Xia Ding, Professor, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03314038     History of Changes
Other Study ID Numbers: 81630080-CAG-CS
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

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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 Dr. Xia Ding, Beijing University of Chinese Medicine:
Chronic Atrophic Gastritis
Malignant Transformation
Syndrome
Traditional Chinese Medicine
Cross-sectional Study

Additional relevant MeSH terms:
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Syndrome
Atrophy
Gastritis
Gastritis, Atrophic
Disease
Pathologic Processes
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases