NCT03297255

Brief Summary

This longitudinal observational cohort study was designed to investigate factors that influencing the occurrence and long-term survival of patients with primary liver cancer. Basic informations and detailed diagnosis informations (AJCC/TNM stage, MELD score, Child-Pugh score, and BCLC stage) were collected by professional doctors. Clinical outcomes (death, recurrence, and metastasis) will be followed up every two years after therapy.

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
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 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

Study Start

First participant enrolled

January 1, 2013

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

12.9 years

First QC Date

September 25, 2017

Last Update Submit

September 27, 2017

Conditions

Keywords

Primary Liver Cancer; Cohort Study

Outcome Measures

Primary Outcomes (1)

  • Time of Death

    The exact death time of each participants will be checked in the government medical records system

    Up to 10 years

Secondary Outcomes (2)

  • Time of recurrence

    From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 10 years

  • Time of metastasis

    From date of diagnosis until the date of cancer metastasis or date of death from any cause, whichever came first, assessed up to 10 years

Eligibility Criteria

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

Patients of this study were invited from Sun Yat-sen University Cancer Center as soon as they were diagnosed as primary liver cancer

You may qualify if:

  • age 18-80 years
  • consistent with primary liver cancer diagnostic criteria
  • first diagnosis (from diagnosis to admission interval of less than a month)
  • did not do any treatment of liver cancer

You may not qualify if:

  • refused to participate in this study
  • suffering from more than two kinds of primary tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (2)

  • Liu ZY, Yishake D, Fang AP, Zhang DM, Liao GC, Tan XY, Zhang YJ, Zhu HL. Serum choline is associated with hepatocellular carcinoma survival: a prospective cohort study. Nutr Metab (Lond). 2020 Mar 30;17:25. doi: 10.1186/s12986-020-00445-z. eCollection 2020.

  • Liu ZY, Tan XY, Li QJ, Liao GC, Fang AP, Zhang DM, Chen PY, Wang XY, Luo Y, Long JA, Zhong RH, Zhu HL. Trimethylamine N-oxide, a gut microbiota-dependent metabolite of choline, is positively associated with the risk of primary liver cancer: a case-control study. Nutr Metab (Lond). 2018 Nov 20;15:81. doi: 10.1186/s12986-018-0319-2. eCollection 2018.

Biospecimen

Retention: SAMPLES WITH DNA

Blood and liver tissue were retented during therapy

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Zhu Huilian, Professor

    Sun Yat-sen University

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 29, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations