Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence

NCT05368636 | Unknown DMC

• 1 other identifier: 2022SDU-QILU-G001
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study combines artificial intelligence with tongue images, by collating and collecting tongue images and diagnostic and pathological results of gastroscopic diseases, mining and analysing the correlation between tongue images and OLGA, OLGIM stages, Correa sequences and constructing prediction models, to deeply investigate the relationship between tongue images and precancerous diseases, precancerous lesions and gastric cancer.

Conditions

Artificial Intelligence; Tongue; Gastric Cancer

Keywords

Artificial Intelligence; tongue; gastric cancer

Outcome Measures

Primary Outcomes (6)

• Sensitivity

  Sensitivity of artificial intelligence models Sensitivity = number of true positives / (number of true positives + number of false negatives) \* 100%.

  3 years

• Specificity

  Specificity of Artificial Intelligence Models Specificity = number of true negatives / (number of true negatives + number of false positives))\*100%

  3 years

• Positive predictive values(PPV)

  Positive predictive values from artificial intelligence models Positive predictive value = true positive / (true positive + false positive)\*100%

  3 years

• Negative predictive values(NPV)

  Negative predictive values for artificial intelligence models Negative predictive value = true negative / (true negative + false negative)\*100%

  3 years

• AUC (95% CI)

  area under the receiver operating characteristic curve (AUC)

  3 years

• Accuracy

  Accuracy of artificial intelligence models Accuracy = (true positives + true negatives) / total number of subjects \* 100%

  3 years

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 40-80 years who will undergo gastroscopy and fulfil the inclusion criteria who do not meet the exclusion criteria.

You may qualify if:

• Patients between 40 and 80 years of age who are scheduled for gastroscopy.
• Patients all gave their informed consent and signed the informed consent form.

You may not qualify if:

• Persons with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who are unable to participate in gastroscopy.
• Patients with previous surgical procedures on the gastrointestinal tract.
• Patients taking bismuth or other staining drugs.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD, PhD

CONTACT

86 15588818685; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctoral supervisor of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

CN (1)