NCT04071431

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34,906

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

August 24, 2019

Last Update Submit

August 26, 2019

Conditions

Early Detection of Cancer

Keywords

Early Detection of cancerGastrointestinal NeoplasmsEndoscopy, Gastrointestinal

Outcome Measures

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.

    up to 24 months

Study Arms (2)

Control

NO INTERVENTION

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

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

Result maskingOTHER

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.

Risk shown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Yanqing LI, Doctor

CONTACT

13573106261liyanqing@sdu.edu.cn

Zhen Li, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2019

First Posted

August 28, 2019

Study Start

May 29, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

CN(1)