A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

NCT ID: NCT04071431

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34906 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Early Detection of Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Risk shown

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.

Group Type EXPERIMENTAL

Result masking

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing LI, Doctor

Role: CONTACT

13573106261

Zhen Li, Doctor

Role: CONTACT

Facility Contacts

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Yanqing Li, PhD. MD.

Role: primary

18678827666

Other Identifiers

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2019SDU-QILU-08

Identifier Type: -

Identifier Source: org_study_id

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