Objective Study on Tongue Diagnosis of Precancerous Lesions of Chronic Atrophic Gastritis and Construction of Prediction Model
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 498
- 主要终点
- Construction of PLGC risk prediction model based on tongue image features
研究概览
简要总结
Chronic atrophic gastritis with intestinal metaplasia or dysplasia is called precancerous lesions of gastric cancer ( PLGC ). It is an important stage in the transformation of normal mucosa to gastric cancer and is significantly associated with the risk of gastric cancer. Early identification of PLGC high-risk groups is the focus of prevention and treatment of gastric cancer. Gastroscopy and pathological examination are the key means to diagnose PLGC. However, due to the invasiveness, high cost, strong professional operability and traumatic pathological sampling, the application of gastroscopy is greatly limited, and the predictive significance of serum markers for the occurrence and prognosis of PLGC is limited. The current PLGC monitoring methods are not targeted enough, and there is still a lack of effective risk prediction models for PLGC. New screening methods are needed to improve the early diagnosis rate of PLGC. Tongue diagnosis is simple, convenient, easy and inexpensive. It can dynamically monitor the risk of PLGC in patients with chronic atrophic gastritis in early real time, and timely formulate individualized intervention measures, which is of great significance for improving the prognosis of patients, controlling medical expenses and truncating disease progression. Based on the objectification of tongue diagnosis, it may become an important method for screening PLGC from the perspective of macroscopic tongue image characteristics and microscopic tongue coating flora.
详细描述
1.1 Research design Study type : Prospective cross-sectional study and clinical prediction model study.
Research hypothesis : Taking PLGC as the observation object, the tongue image and tongue coating flora of PLGC patients were collected objectively and standardized, and the PLGC tongue image research database was established. Based on the characteristics of tongue image and tongue coating flora, the clinical prediction model of PLGC was constructed, so as to realize the real-time dynamic prediction of the risk of PLGC in CAG patients through tongue image, reduce invalid endoscopic screening and reduce the cost of repeated screening.
Research Methods :
( 1 ) Clinical data survey : The questionnaire was used to collect patient information. The baseline data included personal basic information, lifestyle, history of HP infection ( previous HP positive and current HP positive ), history of digestive tract disease and family history of cancer. The medical records also include current medical history, past medical history, personal life history, gastrointestinal adverse symptoms, etc. ; ( 2 ) Electronic endoscopy iodine staining : Olympus electronic endoscopy was used for iodine staining. If any positive or suspicious lesion was found in the gastric mucosa, the corresponding area was bitten and sent for pathological examination. If no abnormality was found by endoscopy, biopsy was not taken. Gastroscopic manifestations ( erosion, ulcer, edema, congestion, erythema, bile reflux, HP infection ) were recorded.
( 3 ) Pathological examination : After the biopsy specimens were processed, the pathological HE staining was performed, and the pathological diagnosis was observed and performed. The histopathological lesions ( chronic inflammation, active inflammation, intestinal metaplasia, atrophy, degree and range of dysplasia ) were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •( 1 ) Upper gastrointestinal endoscopy was performed within 3 months ; ( 2 ) Patients with chronic atrophic gastritis diagnosed by gastroscopy and pathological examination ; ( 3 ) Age 40-70 years old, gender unlimited ; ( 4 ) agreed to collect tongue image and accept follow-up ; ( 5 ) Volunteered to participate in this study and signed informed consent.
排除标准
- •( 1 ) those who cannot cooperate with standardized tongue image collection and data collection ; ( 2 ) patients with tongue scraping, tongue coating or abnormal tongue extension ; ( 3 ) Suspected gastric malignant tendency or gastric tumor and history of gastric surgery ; ( 4 ) Have hepatitis, syphilis, HIV, schistosomiasis and other known infectious diseases ; ( 5 ) patients with severe heart, liver, kidney, blood diseases and malignant tumors ; ( 6 ) Combined with acute respiratory tract infection, active peptic ulcer and other acute diseases ; ( 7 ) Patients who used antibiotics, acid inhibitors and microecological regulators within 1 month ; ( 8 ) long-term use of immunosuppressive agents, hormones and other drugs ; ( 9 ) pregnant or lactating women.
结局指标
主要结局
Construction of PLGC risk prediction model based on tongue image features
时间窗: two years
Univariate conditional Logistic regression analysis was performed on the factors with statistical significance by t test and χ2 test. PLGC was used as the outcome variable to calculate the odds ratio ( OR ) and 95 % confidence interval of each factor. With αin = 0.05, αout = 0.1, the above variables were introduced into Logistic multivariate analysis to screen out the risk factors related to PLGC, and a risk prediction model was established. The receiver operating characteristic ( ROC ) curve was used to represent the ability of the prediction model to distinguish. The goodness of fit and prediction accuracy of the model were evaluated by Hosmer-Lemeshow goodness of fit, Pseudo R-square and area under the curve ( AUC ).
Correlation between tongue image characteristics and PLGC
时间窗: two years
Analysis of tongue color ( pale tongue, pale red tongue, crimson tongue, lavender tongue, ecchymosis tongue ) and tongue shape ( tooth-printed tongue, pricking tongue, ecchymosis tongue, fissured tongue, fat and thin tongue ) in PLGC patients and PLGC correlation ; 2. 2 Analysis of tongue coating characteristics : The correlation between tongue coating quality ( thick and thin coating, greasy coating, rotten coating, peeling coating ) and tongue coating color ( white and yellow ) and PLGC in PLGC patients was analyzed. Analysis of sublingual collaterals : According to the diagnostic criteria of sublingual collaterals grading, the sublingual collaterals were described according to the length, width ( thickness ), tortuosity and color of sublingual collaterals, and the correlation with the pathological changes of PLGC was analyzed. Analysis of tongue color and tongue coating color parameters : RGB, HIS and Lab color space types were used to analyze the RGB, Lab and HSV color space in
次要结局
- Correlation between tongue coating flora and PLGC(two years)