A Novel MSE Score to Predict rHCC Patients | NCT05450874

Studies
A Novel MSE Score to Predict rHCC Patients

NCT05450874

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

Jul 11, 2022Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Interventions

hepatectomy

Countries

Not provided

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

Jun 2022

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

Feb 1, 2010Actual

Primary Completion Date

Mar 1, 2017Actual

Completion Date

Jun 1, 2022Actual

First Submitted Date

Jul 5, 2022

First Submission Date that Met QC Criteria

Jul 8, 2022

First Posted Date

Jul 11, 2022Actual

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 8, 2022

Last Update Posted Date

Jul 11, 2022Actual

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

Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis

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

300Actual

Label	Type	Description	Intervention Names
Training cohort			Procedure: hepatectomy
Validation cohort			Procedure: hepatectomy

Name	Type	Description	Arm Group Labels	Other Names
hepatectomy	Procedure		Training cohort Validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	Time from the first postoperative day to survival at the last follow-up	2010-2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI),
a diagnosis of HCC made by two experienced pathologists

Exclusion Criteria:

extrahepatic HCC metastasis
death within 1 month after surgery

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

A total of 221 patients with rHCC who underwent liver resection from February 2010 to March 2016 at Tongji Hospital and 97 patients with rHCC who underwent hepatectomy at Zhongshan People's Hospital during the same period were included in this study

Sampling Method

Non-Probability Sample

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

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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