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Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation

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ClinicalTrials.gov Identifier: NCT03261934
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : October 17, 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 developed risk assessment and syndrome evolution models of CAG malignant transformation events combining TCM indicators with modern medicine indicators. 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 study patients diagnosed with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and off-site by telephone to track malignant transformation events.

Condition or disease Intervention/treatment
Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation Other: No intervention

Detailed Description:

Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (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. To date, no study has been conducted to assess the risk and syndrome evolution features of CAG malignant transformation by establishing models combining both TCM and modern medicine indicators.

The present study aims to developed risk assessment and syndrome evolution models of CAG malignant transformation events combining TCM indicators with modern medicine indicators. 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 study patients diagnosed with CAG will be recruited. 10-year follow-ups are carried out on-site in hospitals and off-site by telephone to track malignant transformation events. Comparative analysis of prevalence of malignant transformation events and presenting TCM or modern medicine features in different groups is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Correlation analysis of malignant transformation events and TCM or modern medicine factors will be performed using logistic regression, and multivariate Cox proportional hazard model respectively. Exploratory factor analysis, correspondence analysis, association rule analysis, hierarchical clustering analysis, and complex system entropy clustering analysis will also be performed respectively for validating features of syndrome evolution in CAG malignant transformation process.

Previous reports on modern medicine indicators based risk assessment model for ischemic stroke endpoint events exist, but no studies have been undertaken combining TCM features. The risk assessment model combining both TCM and modern medicine indicators has the potential to facilitate early warning, early intervention and early control of CAG malignant transformation. The syndrome evolution model will help evaluate the core TCM pathogenesis of CAG malignant transformation so as to promote optimization of treatment strategies.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Risk Assessment and Syndrome Evolution Models Combining Traditional Chinese Medicine and Modern Medicine Indicators for Chronic Atrophic Gastritis Malignant Transformation: a Registry Study
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. malignant transformation events of chronic atrophic gastritis [ Time Frame: 10 years follow-up ]
    The primary outcome measures will be the malignant transformation events of chronic atrophic gastritis, including gastric mucosal atrophy, intestinal metaplasia, gastric intraepithelial dysplasia, and gastric carcinoma, according to the definition given by "Chronic Gastritis Diagnosis and Treatment Consensus of China (version 2012)", as promulgated by the Society of Gastroenterology, Chinese Medical Association.



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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 registry study conducted in 4 hopitals in Beijing, China, leaded by Beijing University of Chinese Medicine. According to the inclusion and exclusion criteria, 2000 eligible participants will be identified by screening CAG patients after beginning the 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): NCT03261934


Contacts
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Contact: Yin Zhang, MD 86-17710830835 coolzhangyin@sina.com
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

Additional Information:

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Responsible Party: Dr. Xia Ding, Professor, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03261934     History of Changes
Other Study ID Numbers: 81630080-CAG-REG
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Risk Assessment
Syndrome Evolution
Traditional Chinese Medicine
Registry Study
Additional relevant MeSH terms:
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Gastritis
Gastritis, Atrophic
Atrophy
Pathological Conditions, Anatomical
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases