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RecruitingNCT03261934Updated Dec 29, 2020

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

An observational study in Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation, sponsored by Beijing University of Chinese Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-12-29.

Sponsored by Beijing University of Chinese Medicine · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Gastritis, Atrophic with a site in China — 14 open to participants now, 15 under way, none of them phase 3. Gastritis, Atrophic · China.

Planned enrollment
3rd of 16
2,000 · median 358
Started
2018
with 1 other
Observational
16 of 25
11 open now
Primary completion
2030-12
later than 13 of 14 live
Registered
7th of 25
by date
Lead sponsor
3 of 25
Beijing University of Chinese Medicine

Among the 25 studies in Gastritis, Atrophic with a site in China, this one is the 3rd largest by planned enrollment of the 16 observational ones that give a count, is one of 2 that started in 2018, is one of 16 observational ones, reaches primary completion later than 13 of the 14 other live ones, and was the 7th registered.

Gastritis, Atrophic

75 studies on the registry are indexed under Gastritis, Atrophic; 37 are open to participants now.

Browse Gastritis, Atrophic studies →

Open to participants now

14 of the 25 studies in Gastritis, Atrophic with a site in China are open now. Recruiting first, the newest first:

8 more — sign in →

All 14 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 24 Gastritis, Atrophic studies recruiting now, 13 (54%) set no upper age limit and 5 (21%) stop at 75 or younger; none take children under 18; 10 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Risk Assessment of Chronic Atrophic Gastritis Malignant Transformation

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Keywords

  • Chronic Atrophic Gastritis
  • Malignant Transformation
  • Risk Assessment
  • Syndrome Evolution
  • Traditional Chinese Medicine
  • Registry Study
04

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 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. malignant transformation events of chronic atrophic gastritis

    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.

    Time frame: 10 years follow-up

07

Study locations

2 of 2 sites recruiting
  • Dongzhimen Hospital
    Beijing, Beijing 100029, China
    Recruiting
    • Ping Li, Dr. · Contact18801021127
    • Yuan Li, Dr · Principal investigator
  • Wangjing Hospital
    Beijing, Beijing 100102, China
    Recruiting
    • Ping Zhang, Dr. · Contact
    • Ni Lou, Dr · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Dec 2030, 155 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Aug 25, 2017
StartActual
Jan 1, 2018
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2030
Last update
Dec 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03261934
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
Aug 25, 2017
Start date
Jan 1, 2018
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Dec 29, 2020

Study contacts

Yin Zhang, MD
Contact
coolzhangyin@sina.com
86-17710830835
Xia Ding, MD
Contact
dingx@bucm.edu.cn

Oversight

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

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