Integrating Machine Learning for Prognostic Prediction in... | NCT06737367

Studies
Integrating Machine Learning for Prognostic Prediction in Stage I NSCLC by CT Images and Pathological Factors

NCT06737367

Sponsor

Jinling Hospital, China

Status

Completed

Last Update Posted

Dec 19, 2024Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Lung Cancer - Non Small Cell

Interventions

CT radiomic analysis

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Sep 20, 2024Actual

Completion Date

Nov 11, 2024Actual

First Submitted Date

Dec 11, 2024

First Submission Date that Met QC Criteria

Dec 15, 2024

First Posted Date

Dec 17, 2024Actual

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

Dec 16, 2024

Last Update Posted Date

Dec 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators retrospectively collected the participants with stage I non-small cell lung cancer (NSCLC) patients resected between January 2010 to December 2020 for training and internal validation. The Clinical data, preoperative clinical information, laboratory results and CT images were collected. The investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSOcox and rsf were used to select the features. we developed a machine learning-based integrative prognostic model that utilizes radiomic and pathological variables as input using LOOCV framework. And it was further tested on the internal and external cohorts. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), IBS, DCA.

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

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
training set			Other: CT radiomic analysis
external test set			Other: CT radiomic analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT radiomic analysis	Other	Radiomic features of tumor and peritumor tissue	external test set training set

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS（Disease-free survival）	DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.	Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with stage I NSCLC (ninth AJCC edition) who underwent curative R0 resections between January 2010 and December 2020 -

Exclusion Criteria:

absence of enhanced CT
history of lung cancer or synchronous lung cancers
follow-up records ≤3 Months
carcinoma in situ (CIS) or minimally invasive NSCLC
death within 30 days of surgery
no pathological slides or reports

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Jinling Hospital, China

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinling Hospital, China		Nanjing			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
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided