A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Not Applicable

• Conditions: Early Detection of Cancer
• Interventions: Other: Result masking

• Registration Number: NCT04071431
• Lead Sponsor: Yanqing Li

Brief Summary

Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from gastrointestinal cancer remains poor. Endoscopic early diagnosis is a key strategy to improve survival but the detection rate of early cancer varies among different countries. Risk factor questionnaire result is easy to be obtained and may be of great help for improving the detection rate. The aim of this research is to validate a risk factor questionnaire to help predict gastrointestinal cancer therefore allowing earlier diagnosis and higher detection rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Status Verified: 2019-08
• Study First Submitted: 2019-08-24
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34906

Inclusion Criteria

• Patients aged more than 18 years with or without GI symptoms attending for endoscopy.

Exclusion Criteria

• Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk shown	Result masking	During the application stage of endoscopy, the patients are required to complete a RFQ according to their own situations. The RFQs will soon uploaded to the core server of the quality control system and be analysed automatically immediately after finish. The results are sorted into four types including "N/A", "High-risk for esophageal cancer", "High-risk for gastric cancer" and "High-risk for colorectal cancer", which will be shown during the endoscopy of the specific person. The endoscopies are carried out by experienced endoscopists. All of the data of the endoscopy itself are collected and recorded in the quality control system. The RFQ results of this group are known by the endoscopists before and during the endoscopy.

Primary Outcome Measures

Name	Time	Method
Rate change	up to 24 months	The endoscopic detection rate change of precancerous lesions and early GI cancer with the help of self-rating RFQ for the prediction of GI cancer.

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China