NCT05286099

Brief Summary

Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

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 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

February 22, 2022

Last Update Submit

March 17, 2022

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Effective detection of early hepatocellular carcinoma

    The occurrence of early hepatocellular carcinoma

    2 years

Interventions

Imaging examination and/or blood testOTHER

Imaging examination and/or blood test will be performed at a certain time

Eligibility Criteria

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

Patients with hepatitis B, liver cirrhosis, or atypical hyperplasia nodules confirmed or suspected by enhanced imaging examination will be enrolled, the contrast-enhanced ultrasound and/or enhanced magnetic resonance imaging will be performed every three months or half a year to observe the size and contrast-enhanced features of the nodules. If the size or enhancement features change, there will a puncture biopsy under the guidance of ultrasound, and if malignant tumor cells are found, the follow-up will be terminated.

You may qualify if:

  • \- Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer.

You may not qualify if:

  • \- Can't tolerate the enhanced imaging examination Poor medical compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Chinese PLA general hospital

Beijing, 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chinese PLA General Hospital

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 18, 2022

Study Start

January 15, 2022

Primary Completion

July 1, 2023

Study Completion

December 31, 2023

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

CN(2)