NCT05297955

Brief Summary

The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

2.7 years

First QC Date

March 17, 2022

Last Update Submit

March 27, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma

    The previous CTC detection data of 458 cases was collected. To compare the relationship between CTC level of perioperative peripheral blood and clinical indexes of HCC patients, the main statistical analysis were one-way ANOVA, Student's T test and Multivariable Cox regression.

    2022.03.15

Study Arms (2)

The number of CTC in HCC patient great than or equal to two

According to the cutoff of CTC, the number of CTC in HCC patient great than or equal to two

The number of CTC in HCC patient less than two

According to the cutoff of CTC,the number of CTC in HCC patient less than two

Eligibility Criteria

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

Perioperative patients with hepatocellular carcinoma who underwent CTC detection of peripheral blood

You may qualify if:

  • The pathological diagnosis was primary liver cancer.
  • Undergoing radical surgical treatment
  • No preoperative antitumor therapy was received
  • Between 18 and 80 years old

You may not qualify if:

  • With distal metastasis
  • With other tumors
  • Perioperative death
  • Recurrence within one month after surgery
  • Lost contact before the first follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiaoping Chen

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of surgery department

Study Record Dates

First Submitted

March 17, 2022

First Posted

March 28, 2022

Study Start

November 1, 2013

Primary Completion

June 30, 2016

Study Completion

March 15, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations