A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Yanqing Li

Status: Unknown

Conditions: Early Detection of Cancer

Treatments: Other: Result masking

Study type: Interventional

Funder types: Other

Identifiers

NCT04071431

2019SDU-QILU-08

Details and patient eligibility

About

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.

Enrollment: 34,906 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34,906 participants in 2 patient groups

Control

No Intervention group

Description:

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 not known (deliberately showing "N/A") by the endoscopists before and during the endoscopy.

Risk shown

Experimental group

Description:

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.

Treatment:

Other: Result masking