ML Models for Predicting Postoperative Peritoneal Metasta... | NCT06102278

Studies
ML Models for Predicting Postoperative Peritoneal Metastasis After Hepatocellular Carcinoma Rupture

NCT06102278

Sponsor

Chen Xiaoping

Status

Completed

Last Update Posted

Oct 26, 2023Actual

Enrollment

522Actual

Phase

Not provided

Conditions

Peritoneal Metastasis

Interventions

Peritoneal Metastasis

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

Oct 2023

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

Jan 1, 2020Actual

Primary Completion Date

Mar 1, 2023Actual

Completion Date

Apr 1, 2023Actual

First Submitted Date

Oct 22, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 26, 2023Actual

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

Oct 25, 2023

Last Update Posted Date

Oct 26, 2023Actual

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

This study aimed to address the issue of peritoneal metastasis (PM) following the rupture of hepatocellular carcinoma (HCC) and its adverse impact on patient prognosis. Clinical data from 522 patients with ruptured HCC who underwent surgery at seven different medical centers were collected and analyzed. Machine learning models were employed for analysis and prediction.

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

522Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training cohort		All cases were randomly grouped according to 7:3, with 70% defined as the training group	Other: Peritoneal Metastasis
Validation cohort		All cases were randomly grouped according to 7:3, with 30% defined as the validation group	Other: Peritoneal Metastasis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peritoneal Metastasis	Other	Patients experiencing postoperative peritoneal metastasis	Training cohort Validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	Overall survival (OS) was defined as the time from the date of surgery to death	2018-2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:(1) HCC confirmed by pathologists (2) two preoperative imaging findings suggestive of tumor rupture (3) R0 resection (4) first tumor detection -

Exclusion Criteria:(1) previous antitumor therapy (2) combination of other types of tumors (3) incomplete clinical data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

522 rHCC patients who underwent radical hepatectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided