NCT06623734

Brief Summary

This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. The eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
226mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2025Dec 2044

First Submitted

Initial submission to the registry

September 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2039

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2044

Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

14.8 years

First QC Date

September 30, 2024

Last Update Submit

March 3, 2025

Conditions

Liver Neoplasms

Keywords

Primary liver cancerHepatocellular carcinomaIntrahepatic cholangiocarcinomaPrognosisProspective cohort study

Outcome Measures

Primary Outcomes (1)

  • Death

    The primary endpoint of this study is all-cause mortality and liver caner-specific mortality. The exact death time and the cause of death of each participant will be checked in the government medical records system.

    Up to 20 years

Secondary Outcomes (9)

  • Recurrence (intrahepatic and extrahepatic)

    From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 20 years

  • Newly Emerging Diseases

    From date of diagnosis until the date of newly emerging diseases or date of death from any cause, whichever came first, assessed up to 20 years

  • Response Evaluation

    through study period, every 3-6 months

  • Nutritional status

    through study period, every 3-6 months

  • Quality of life

    through study period, every 3-6 months

  • +4 more secondary outcomes

Eligibility Criteria

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

Patients newly diagnosed with primary liver cancer

You may qualify if:

  • Age 18-80 years,
  • Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" and the "2024 CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies),
  • Have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc),
  • Signed informed consent.

You may not qualify if:

  • Have a history of other malignant tumors,
  • Have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.),
  • Expected survival time is no more than 3 months,
  • Severe physical or mental disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

liver tissues, blood, urine, and stools

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularCholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Aiping Fang, MBBS, PhD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Yanjun Zhang, MBBS, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aiping Fang, MBBS, PhD

CONTACT

+86 20 87335189fangaip@mail.sysu.edu.cn

Yaojun Zhang, MBBS, MD

CONTACT

+86 20 87343117zhangyuj@sysucc.org.cn

Study Design

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

Study Record Dates

First Submitted

September 30, 2024

First Posted

October 2, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

December 31, 2039

Study Completion (Estimated)

December 31, 2044

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)