Clinical Evaluation of GRAPE Model for Gastric Cancer Scr... | NCT07067983

Studies
Clinical Evaluation of GRAPE Model for Gastric Cancer Screening

NCT07067983

Sponsor

Zhejiang Cancer Hospital

Status

Recruiting

Last Update Posted

Jul 16, 2025Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Results following systematic screening

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2025Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jul 6, 2025

First Submission Date that Met QC Criteria

Jul 6, 2025

First Posted Date

Jul 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2025

Last Update Posted Date

Jul 16, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Prospective Study Evaluating the Performance of the GRAPE Model in Gastric Cancer Screening and Its Detection Rates Across Different Disease Stages

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Results following systematic screening	Diagnostic Test	The GRAPE model's output (positive or negative) determines whether patients require follow-up gastroscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
GRAPE systematic screening results	Screen-positive individuals after GRAPE systematic screening	first visited at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 18 and 80 years
Individuals undergoing thoracoabdominal CT examination
Voluntarily participated in the study and provided written informed consent

Exclusion Criteria:

Patients with confirmed diagnosis of gastric cancer
Individuals with severe intellectual disabilities or communication disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals undergoing thoracoabdominal CT examination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangdong Cheng	Contact	0086-571-881280		chengxd@zjcc.org.cn
Can Hu	Contact	13968032995		chengxd@zjcc.org.cn

Overall Officials

Name	Affiliation	Role
Xiangdong Cheng	Zhejiang Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)	Recruiting	Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided