Ignite Creation Date:
2024-05-06 @ 10:27 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03261934
Status:
RECRUITING
Last Update Posted:
2020-12-29
First Post:
2017-08-22
Brief Title:
Risk Assessment and Syndrome Evolution Models for Chronic Atrophic Gastritis Malignant Transformation
Sponsor:
Beijing University of Chinese Medicine
Organization:
Beijing University of Chinese Medicine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None