Prognostic Models for HCC Based on Tumor Micronecrosis | NCT05837065

Studies
Prognostic Models for HCC Based on Tumor Micronecrosis

NCT05837065

Sponsor

Zhejiang University

Status

Unknown status

Last Update Posted

May 1, 2023Actual

Enrollment

765Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

observing whether HCC patients having tumor micronecrosis

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2022Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Apr 17, 2023

First Submission Date that Met QC Criteria

Apr 27, 2023

First Posted Date

May 1, 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

Apr 27, 2023

Last Update Posted Date

May 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.

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

765Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
training cohort		HCC patients receiving curative hepatic resection	Other: observing whether HCC patients having tumor micronecrosis
validation cohort		HCC patients receiving curative hepatic resection	Other: observing whether HCC patients having tumor micronecrosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observing whether HCC patients having tumor micronecrosis	Other	whether HCC patients having tumor micronecrosis or not	training cohort validation cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the Harrell concordance index (C-index)		Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
the time-dependent area under the receiver operating characteristic curve(tdAUROC)		Up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathologically diagnosed as HCC;
curative hepatectomy with R0 resection;
conserved liver function with Child Pugh class A or B

Exclusion Criteria:

with macrovascular invasion or extrahepatic metastasis;
receiving other anti-tumor treatments such as TACE or systemic drugs;
with other primary cancers;
incomplete follow-up data;
without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

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

This retrospective study enrolled HCC patients receiving curative hepatectomy in the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 765)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tingbo Liang, PhD	Contact			liangtingbo@zju.edu.cn
Qi Zhang, MD	Contact	13819137113		qi.zhang@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310003	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
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided