Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

NCT ID: NCT03314038

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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TCM Syndrome of Chronic Atrophic Gastritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Science and Technology of China

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

Beijing University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Dr. Xia Ding

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xia Ding, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Medicine

Locations

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Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yin Zhang, MD

Role: CONTACT

Xia Ding, MD

Role: CONTACT

Facility Contacts

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Xia Ding, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 30166291 (View on PubMed)

Other Identifiers

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81630080-CAG-CS

Identifier Type: -

Identifier Source: org_study_id

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