Gastric CancerNCT05470452

Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software

A study testing The reading process is assisted by ENDOANGEL and No ENDOANGEL assistance during the reading process in people with Gastric Cancer, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software developed by Wuhan ENDOANGEL Medical Technology Co., Ltd. is used for the identification of gastric cancer in endoscopic magnification mode in definitive images to assist in the diagnosis of upper gastrointestinal gastric cancer lesions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Gastric Cancer
What is being tested?: The reading process is assisted by ENDOANGEL and No ENDOANGEL assistance during the reading process
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 340 participants
Where: 1 siteChina
Study dates: 28 Jul 2021to Aug 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18, male or female；
Cases with complete, clear imaging data, including images under white light and magnified stained images；
Complete pathological diagnosis of upper digestive tract lesions;
The included cases were excluded from the software development.

Who cannot join

Cases whose image data did not meet the evaluation requirements;
The investigator considered the case unsuitable for the clinical trial.

Trial locations and contacts

1 site in 1 country.

Song He, MD contact

+8613808336120

dengchao1990@hospital.cqmu.edu.cn

China1 site, 1 recruiting

The Second Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Chao Deng, +8615123172616, dengchao1990@hospital.cqmu.edu.cn
Recruiting

Other trials in China

About this study

Conditions: Gastric Cancer
Being tested: The reading process is assisted by ENDOANGEL, No ENDOANGEL assistance during the reading process
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The reading process is assisted by ENDOANGELOther
Diagnosis of benign and malignant lesions with the help of ENDOANGEL
No ENDOANGEL assistance during the reading processOther
Diagnosis of benign and malignant lesions without the help of ENDOANGEL

Study groups in NCT05470452
Study group	Role	What they receive
Physician AI-assisted diagnosis group	Experimental	Not described Receives: Other: The reading process is assisted by ENDOANGEL
Physician Independent Diagnostic Group	Sham comparator	Not described Receives: Other: No ENDOANGEL assistance during the reading process

What is being measured

The primary outcome is the main question the study is designed to answer.

AFROC-AUC
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.
Measured: 3 months

Secondary outcomes (3)

Cancer identification Sensitivity
The numerator is the number of true positives and the denominator is the total number of true positives and false negatives.
Measured: 3 months
Cancer identification specificity
The numerator is the number of true negatives and the denominator is the total number of true negatives and false positives.
Measured: 3 months
Cancer Identification Diagnosis Compliance Rate
The numerator is the total number of true positives plus true negatives, and the denominator is the total number of true positives, false positives, true negatives, and false negatives.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 2021Aug 2022

First posted22 Jul 2022
Study start28 Jul 2021
Primary completionAug 2022 (estimated)
Study completionAug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 340 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470452
Sponsor's protocol ID: EndoAngel -CTP-02
Status last verified: Jul 2022
First submitted: 20 Jul 2022
Last updated: 22 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validating the Safety and Effectiveness of ENDOANGEL Upper Gastrointestinal Endoscope Image Auxiliary Diagnostic Software
ClinicalTrials.gov ID: NCT05470452
Acronym / sponsor ID: EndoAngel -CTP-02
Conditions: Gastric Cancer
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 340 participants (estimated)
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
Study start: 28 Jul 2021 (actual)
Primary completion: Aug 2022 (estimated)
Study completion: Aug 2022 (estimated)
First posted: 22 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Physician AI-assisted diagnosis group	Experimental	Other: The reading process is assisted by ENDOANGEL
Physician Independent Diagnostic Group	Sham comparator	Other: No ENDOANGEL assistance during the reading process

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18, male or female；
Cases with complete, clear imaging data, including images under white light and magnified stained images；
Complete pathological diagnosis of upper digestive tract lesions;
The included cases were excluded from the software development.

Key exclusion criteria (2 listed)

Cases whose image data did not meet the evaluation requirements;
The investigator considered the case unsuitable for the clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The reading process is assisted by ENDOANGELDiagnosis of benign and malignant lesions with the help of ENDOANGEL	Other	Physician AI-assisted diagnosis group
No ENDOANGEL assistance during the reading processDiagnosis of benign and malignant lesions without the help of ENDOANGEL	Other	Physician Independent Diagnostic Group

Primary outcome

AFROC-AUC
Time frame: 3 months
AFROC-AUC at the level of identified lesions in the upper gastrointestinal cancers in the trial and control groups, using a between-group comparison.

3 secondary outcomes

Cancer identification Sensitivity
Time frame: 3 months
Cancer identification specificity
Time frame: 3 months
Cancer Identification Diagnosis Compliance Rate
Time frame: 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Song He, MD contact

+8613808336120

dengchao1990@hospital.cqmu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Song He, MD (+8613808336120, dengchao1990@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AFROC-AUC (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.