CClinicalTrials.gg
Status unknownNCT04071431Updated Aug 28, 2019

A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

An interventional study of Result masking in Early Detection of Cancer, sponsored by Yanqing Li. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Yanqing Li · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
34,906
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Early Detection of Cancer

Keywords

  • Early Detection of cancer
  • Gastrointestinal Neoplasms
  • Endoscopy, Gastrointestinal
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In context

Gastrointestinal Neoplasms

779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.

This study's planned enrollment of 34,906 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.

Browse Gastrointestinal Neoplasms studies →

Lead sponsor

Yanqing Li is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34,906 participants (estimated)

Study arms

  • No intervention
    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.

  • Experimental
    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.

    Other: Result masking

Interventions

  • OtherResult 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04071431
Lead sponsor
Yanqing Li
Responsible party
Yanqing Li (Professor, Shandong University) — Sponsor-investigator
First posted
Aug 28, 2019
Start date
May 29, 2019
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Aug 28, 2019

Study contacts

Yanqing LI, Doctor
Contact
liyanqing@sdu.edu.cn
13573106261
Zhen Li, Doctor
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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