NCT03880721

Brief Summary

Developing a radiomics model to predict the prognosis of patients with hepatocellular carcinoma after microwave ablation to provide advice for their treatment.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.6 years

First QC Date

March 17, 2019

Last Update Submit

May 22, 2019

Conditions

Hepatocellular Carcinoma

Keywords

radiomicsprognosis

Outcome Measures

Primary Outcomes (3)

  • AUC value

    Utilizing area under curve to judge the accurency

    through study completion, an average of 2 year

  • Sensitivity

    diagnosis sensitivity of intelligent ultrasound analysis

    through study completion, an average of 2 year

  • Specificity

    diagnosis specificity of intelligent ultrasound analysis

    through study completion, an average of 2 year

Study Arms (6)

Good prognosis

Procedure: Microwave abaltion

Poor prognosis

Procedure: Microwave abaltion

Recurrence

Procedure: Microwave abaltion

Not Recurrence

Procedure: Microwave abaltion

Survival

Procedure: Microwave abaltion

Death

Procedure: Microwave abaltion

Interventions

Microwave abaltionPROCEDURE

Use microwave ablation to treat hepatocellular carcinoma

DeathGood prognosisNot RecurrencePoor prognosisRecurrenceSurvival

Eligibility Criteria

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

Patients with primary hepatocellular carcinoma

You may qualify if:

  • Patients with primary hepatocellular carcinoma in the department of interventional ultrasound, PLA general hospital, who accept MWA therapy for HCC
  • Primary hepatocellular
  • No other treatments ware performed before microwave ablation
  • Patient has been clinically diagnosed with HCC definitely, and have a definite operational indication
  • No extrahepatic manifestations and no evidence of vessel invasion and bile duct thrombi

You may not qualify if:

  • Non-primary hepatocellular carcinoma or hepatic metastases
  • Accept other treatment before microwave ablation
  • Extrahepatic metastasis, vessel invasion or bile duct thrombi

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

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jie Yu, Dr

CONTACT

8610-66939530yu-jie301@hotmail.com

Ping Liang, Dr

CONTACT

8610-66939530liangping301@hotmail.com

Study Design

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

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 19, 2019

Study Start

January 1, 2019

Primary Completion

August 1, 2020

Study Completion

April 1, 2021

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

CN(1)