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A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Primary Purpose

Early Detection of Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Result masking

About this trial

This is an interventional screening trial for Early Detection of Cancer focused on measuring Early Detection of cancer, Gastrointestinal Neoplasms, Endoscopy, Gastrointestinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Risk shown

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04071431

First Posted

August 24, 2019

Last Updated

August 26, 2019

Sponsor

Yanqing Li

1. Study Identification

Unique Protocol Identification Number

NCT04071431

Brief Title

A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 29, 2019 (Actual)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yanqing Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Detection of Cancer

Keywords

Early Detection of cancer, Gastrointestinal Neoplasms, Endoscopy, Gastrointestinal

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34906 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Risk shown

Arm Type

Experimental

Arm 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.

Intervention Type

Other

Intervention Name(s)

Result masking

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate change

Description

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.

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yanqing LI, Doctor

Phone

13573106261

liyanqing@sdu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Li, Doctor

Facility Information:

Facility Name

Department of Gastroenterology, Qilu Hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanqing Li, PhD. MD.

Phone

18678827666

liyanqing@sdu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

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