Artificial Intelligence for Pathology Diagnosis and Progn... | NCT07098884

Studies
Artificial Intelligence for Pathology Diagnosis and Prognosis Prediction of Lung Nodule Using Smartphone Photos

NCT07098884

Sponsor

Anhui Provincial Hospital

Status

Recruiting

Last Update Posted

Aug 1, 2025Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Artificial Intelligence
Lung Nodule

Interventions

AI model

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

Jun 1, 2025Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Oct 30, 2025Estimated

First Submitted Date

Jul 3, 2025

First Submission Date that Met QC Criteria

Jul 30, 2025

First Posted Date

Aug 1, 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 30, 2025

Last Update Posted Date

Aug 1, 2025Actual

Name	Class
The First Affiliated Hospital of Soochow University	OTHER
Ningbo No. 1 Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current study aims to develop and validate a deep learning signature for diagnosing pathology and predicting prognosis of lung nodule using smartphone photos of resected tumor specimens.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AI model	Diagnostic Test	AI model developed by smartphone photos of resected tumor specimens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the receiver operating characteristic curve		From enrollment to the end of the study, assessed up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Age ranging from 20-75 years.

Exclusion Criteria: (1) Participants with incomplete clinical information; (2) Participants who have received anti-tumor therapy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients receiving surgery for lung nodule

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yifan Zhong, PhD	Contact	0551-62283114		jiqingqing0229@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anhui Provincial Hospital	Recruiting	Hefei	Anhui	230000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data involve patient privacy and requires strict data protection measures

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided