NCT04640363

Brief Summary

Combined F index, A index,ATT index and spleen stiffness to predict tumor recurrence in different liver settings after thermal ablation of HCC.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

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

First Submitted

Initial submission to the registry

November 10, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.1 years

First QC Date

November 10, 2020

Last Update Submit

January 13, 2021

Conditions

HCCRecurrence Tumor

Keywords

Thermal ablationElastographyUltrasoundRecurrencePredictive Cancer Model

Outcome Measures

Primary Outcomes (4)

  • F index

    F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.

    baseline

  • A index

    A index is linked to the degree of hepatitis,and it can be available by ultrasound elastography checking.

    baseline

  • ATT index

    ATT index is linked to the degree of steatosis of liver,and it can be available by ultrasound elastography checking.

    baseline

  • Spleen stiffness

    Spleen stiffness can be available by ultrasound elastography checking.

    baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who underwent thermal ablation of HCC will be observed and evaluate the predictive power of combined elastography for tumor recurrence.

You may qualify if:

  • Aged 18 to 80 years of age, and gender not limited;Chronic hepatitis B patients;The lesions of liver have the histopathological diagnosis of HCC and within MiLan criteria;All lesions were performed thermal ablation surgery;Sign the informed consent.

You may not qualify if:

  • Lesions that unrealized complete inactivation evaluation by the enhanced imaging;Merging other systems' serious illness that can't cooperate with elastic imaging checking(such as heart failure, renal failure, such as mental illness);After liver transplantation patients;Patients with pregnancy.

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

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ping Liang, Doctor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

010-66937981yu-jie301@hotmail.com

Study Design

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

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 23, 2020

Study Start

December 1, 2020

Primary Completion

December 31, 2023

Study Completion

May 31, 2024

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

CN(1)