NCT06331260

Brief Summary

As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Apr 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 Progress52%
Apr 2024Apr 2028

First Submitted

Initial submission to the registry

March 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Liver TransplantationHepatocellular CarcinomaAlpha-FetoproteinProtein Induced by Vitamin K Absence or Antagonist-II

Outcome Measures

Primary Outcomes (3)

  • Recurrence free survival rate

    2024.4.1-2028.4.1

  • Overall survival rate

    2024.4.1-2028.4.1

  • Tumor recurrence rate

    2024.4.1-2028.4.1

Study Arms (2)

Preoperative AFP < 400 ng/mL or PIVKA-II < 200mAU/mL

Preoperative AFP ≥ 400 ng/mL and PIVKA-II ≥ 200mAU/mL

Eligibility Criteria

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

HCC patients who undergoing deceased donor liver transplantation for the first time.

You may qualify if:

  • Diagnosis of HCC based on CT or MRI imaging or needle biopsy confirming a histologic diagnosis of HCC.
  • Patients undergoing deceased donor liver transplantation for the first time.

You may not qualify if:

  • (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up, (5) taking warfarin at the time of LT biomarker measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Professor

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 26, 2024

Study Start

April 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

March 26, 2024

Record last verified: 2024-03