NCT03221049

Brief Summary

Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Hence,investors try to combine radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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, 2011

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

12 years

First QC Date

July 14, 2017

Last Update Submit

September 1, 2021

Conditions

Keywords

diagnosis performancehepatocellular carcinomaliver fibrosisprogression

Outcome Measures

Primary Outcomes (3)

  • liver fibrosis

    the degree of liver fibrosis

    1 year

  • benign or malignance

    the malignance of liver space occupying lesions

    5 years

  • The incidence of recurrence

    the incidence of liver cancer recurrence after ablation

    5 years

Study Arms (3)

chronic hepatitis B patients

ultrasound and radiomics

Diagnostic Test: radiomics

patients with liver space occupying lesions

ultrasound and radiomics

Diagnostic Test: radiomics

patients undergo ablation

ablation, ultrasound and radiomics

Diagnostic Test: radiomics

Interventions

radiomicsDIAGNOSTIC_TEST
chronic hepatitis B patientspatients undergo ablationpatients with liver space occupying lesions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic hepatitis B patients /patients with liver space occupying lesions / patients after ablation

You may qualify if:

  • HBsAg positive or HBV-DNA detected
  • agreed to undergo liver biopsy
  • agreed to participated in our study

You may not qualify if:

  • combined with other liver disease(eg. HAV/HCV/HDV,alcoholic liver disease)
  • combined with HIV
  • combined with malignant liver space occupying lesions
  • liver transplantation
  • pregnant
  • the sample size of liver biopsy could not demand: length lower than 15mm, portal areas less than 6.
  • For patients classified between benign and malignant tumor
  • patients diagnosed with liver space occupying lesions
  • with histology results of liver space occupying lesions.
  • agreed to participate in our study and signed informed consent.
  • ultrasound images cant meet the demand for analysis
  • without histology results
  • For patients to estimate progression after ablation
  • patients diagnosed with hepatocellular carcinoma;
  • patients treated with ablation;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The department of Ultrasound, the third affiliated hospital of Sun Yat-son University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hepatitis BCarcinoma, HepatocellularLiver CirrhosisDisease Progression

Interventions

Radiomics

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • rongqin zheng, doctor

    The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

January 1, 2011

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations