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NCT04071431 Clinical Trial

A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Early Detection of Cancer Clinical Trial

Official title:
A Self-rating Risk Factor Questionnaire for the Improvement of Endoscopic Prediction of Gastrointestinal Cancer: a Big-data-based Diagnostic Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04071431
Other study ID # 2019SDU-QILU-08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date April 2021

Study information
Verified date August 2019
Source Shandong University
Contact Yanqing LI, Doctor
Phone 13573106261
Email liyanqing@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 34906
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Result masking
The quality control system randomly shows the RFQ result to the endoscopists and keep 50% of the RFQ results are not known (deliberately showing "N/A") by the endoscopists before and during the endoscopy.

Locations
Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)
Lead Sponsor Collaborator
Yanqing Li

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate change 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. up to 24 months
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