Objective Study on Tongue Diagnosis of Chronic Atrophic Gastritis

NCT06489132 | Not Yet Recruiting DMC

• 2 other identifiers: YangSS2024SF49
• Study Type: observational
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Atrophic Gastritis

Keywords

Gastric precancerous lesions; tongue diagnosis; objectification; tongue coating flora; prediction model

Outcome Measures

Primary Outcomes (2)

• Correlation between tongue image characteristics and PLGC

  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

  two years

• Construction of PLGC risk prediction model based on tongue image features

  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 ).

  two years

Secondary Outcomes (1)

• Correlation between tongue coating flora and PLGC

  two years

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first hospital of Peking University was selected as the research site, and CAG patients who underwent upper gastrointestinal endoscopy and were pathologically diagnosed as PLGC were selected as the research objects. According to gender and age matching, the control group was confirmed by gastroscopy as non-PLGC CAG patients. All participants were informed of the objectives, procedures, potential risks and benefits of the study and then signed a consent form.

You may qualify if:

• ( 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.

You may not qualify if:

• ( 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

The samples of tongue coating flora were collected and stored at-80 °C refrigerator. Utilization : not used for product development, sharing and secondary utilization ; privacy protection : identified by research number rather than your name ; destruction treatment : centralized destruction after completion of flora analysis.

MeSH Terms

Conditions

Gastritis, Atrophic

Condition Hierarchy (Ancestors)

Gastritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Shanshan Yang, Dr

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Shanshan Yang, Dr

CONTACT

0086-10-83575051; shanshanyangssy@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07