Prognostic Models for HCC Based on Tumor Micronecrosis

• Sponsor: Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05837065
• Collaborator: (none)
• Enrollment: 765
• Location: 1
• Anticipated Duration (Months): 15.5
• Patients Per Site Per Month: 49.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Other: observing whether HCC patients having tumor micronecrosis

Study Design

• Study Type: Observational
• Anticipated Enrollment: 765 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Development and Validation of Novel Models Including Tumor Micronecrosis for Predicting the Postoperative Survival of Patients With Hepatocellular Carcinoma
• Actual Study Start Date: Sep 15, 2022
• Actual Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
training cohort HCC patients receiving curative hepatic resection	Other: observing whether HCC patients having tumor micronecrosis; whether HCC patients having tumor micronecrosis or not
validation cohort HCC patients receiving curative hepatic resection	Other: observing whether HCC patients having tumor micronecrosis; whether HCC patients having tumor micronecrosis or not

Outcome Measures

Primary Outcome Measures

1. the Harrell concordance index (C-index) [Up to 5 years]

Secondary Outcome Measures

1. the time-dependent area under the receiver operating characteristic curve(tdAUROC) [Up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. pathologically diagnosed as HCC;

2. curative hepatectomy with R0 resection;

3. conserved liver function with Child Pugh class A or B

Exclusion Criteria:

1. with macrovascular invasion or extrahepatic metastasis;

2. receiving other anti-tumor treatments such as TACE or systemic drugs;

3. with other primary cancers;

4. incomplete follow-up data;

5. without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TingBo Liang, Director, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05837065
• Other Study ID Numbers: PMforHCC
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by TingBo Liang, Director, Zhejiang University: Hepatocellular Carcinoma; Tumor micronecrosis; Nomogram
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 1, 2023