NCT05257694

Brief Summary

Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

February 13, 2022

Last Update Submit

October 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival (RFS)

    Recurrence-free survival is defined as the time elapsed between a predefined point in time (the date of diagnosis, randomization or the intervention) and any recurrence (local, regional, or distant) or death due to any cause (death is an event).

    Immediately after the surgery or ablation

Secondary Outcomes (1)

  • Recurrence

    Immediately after the surgery or ablation

Interventions

SurgeryPROCEDURE

hepatectomy

Eligibility Criteria

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

patients with HCC corresponding to Ia, Ib, IIa stage (China liver cancer staging) who undergo resection or ablation.

You may qualify if:

  • patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation
  • without macro-vascular invasion
  • Child-Pugh A/B grade
  • HCC is proved by pathological examination or two enhanced imaging
  • CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation
  • Invasive biomarker or prognosis of HCC available
  • CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)

You may not qualify if:

  • postop follow-up loss or expired less than 3 months
  • patients with co-malignancy
  • poor images quality for analyzing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, OperativeRadiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of department of interventional ultrasound

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 25, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations