NCT06750159

Brief Summary

Based on the clue that the serum marker AKR1B10 found in the investigators' previous study can be used as an effective indicator for detecting HCC and preHCC, the role and value of AKR1B10 as a new tumor marker for evaluating the recurrence monitoring of HCC after radical surgical resection needs further study, as to provide detailed clinical research data and scientific basis for improving the survival rate of HCC patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Dec 2024

Longer than P75 for all trials

Status
not yet recruiting

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 Progress28%
Dec 2024Dec 2029

First Submitted

Initial submission to the registry

December 12, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Expected
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 12, 2024

Last Update Submit

December 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • post-operation recurrence or death

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.

Interventions

no intervention(observational study)

Eligibility Criteria

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

Patients who have diagnosed with hepatocellular carcinoma

You may qualify if:

  • Meets the diagnostic criteria of primary hepatocellular carcinoma.
  • Meet the criteria for radical resection of hepatocellular carcinoma.
  • No anti-cancer treatment before the first diagnosis.

You may not qualify if:

  • Patients who are pregnant or nursing.
  • Patients with incomplete clinical data, serological and imaging findings.
  • Patients who were lost to follow-up before the observation endpoint.
  • Complicated with serious heart, brain, lung, kidney, hematopoietic and other system diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual serum of patients' routine blood tests

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Shunda Du, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Liver Surgery Department

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 27, 2024

Study Start

December 16, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2029

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial