CClinicalTrials.gg
Status unknownNCT03314038Updated Feb 1, 2021

Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

An observational study in TCM Syndrome of Chronic Atrophic Gastritis, sponsored by Beijing University of Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Beijing University of Chinese Medicine · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • TCM Syndrome of Chronic Atrophic Gastritis

Keywords

  • Chronic Atrophic Gastritis
  • Malignant Transformation
  • Syndrome
  • Traditional Chinese Medicine
  • Cross-sectional Study
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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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.

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

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. TCM syndrome

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

    Time frame: one time at involvement (1 day)

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Study locations

1 of 1 sites recruiting
  • Beijing University of Chinese Medicine
    Beijing, Beijing 100029, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 30166291 ↗
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Registry details

Key details

Study ID
NCT03314038
Lead sponsor
Beijing University of Chinese Medicine
Collaborators
The University of Science and Technology of China, China Academy of Chinese Medical Sciences, Harvard Medical School (HMS and HSDM)
Responsible party
Dr. Xia Ding (Professor, Beijing University of Chinese Medicine) — Principal investigator
First posted
Oct 19, 2017
Start date
Jan 1, 2014
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Feb 1, 2021

Study contacts

Yin Zhang, MD
Contact
coolzhangyin@sina.com
Xia Ding, MD
Contact
dingx@bucm.edu.cn
Xia Ding, MD
principal investigator · Beijing University of Chinese Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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