NCT06102278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

3.2 years

First QC Date

October 22, 2023

Last Update Submit

October 25, 2023

Conditions

Peritoneal Metastasis

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Overall survival (OS) was defined as the time from the date of surgery to death

    2018-2023

Study Arms (2)

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

Peritoneal MetastasisOTHER

Patients experiencing postoperative peritoneal metastasis

Training cohortValidation cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

522 rHCC patients who underwent radical hepatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

January 1, 2020

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

CN(1)