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Hepatocellular CarcinomaNCT05371873

A Study of Chromosomal Abnormalities as a Predictor of Staging and Prognosis in Patients With Liver Cancer

An observational study of Hepatocellular Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Liver cancer is one of the most common malignant tumors worldwide with high morbidity and mortality, and hepatocellular carcinoma (HCC) is the main histological subtype. So far, liver resection is the most effective treatment but the postoperative recurrence rate is high at five years, and the prognosis is difficult… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Liver resection method
Type of treatment
Surgery or procedure
How many people
250 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The investigators recruit patients dignosed with hepatocellular carcinoma without severe complications and other cancers. These patients eventually undergo liver resection.

Who may be able to join

  • 18 to 80 years old;
  • clinical diagnosis of liver cancer;
  • intend to perform surgical treatment;
  • postoperative pathological diagnosis of hepatocellular carcinoma;
  • signed informed consent.

Who cannot join

  • Not diagnosed with liver mass;
  • Not undergo liver resection;
  • Postoperative pathological diagnosis of non-hepatocellular carcinoma;
  • Under the age of 18 or over 80;
  • Concomitant pregnancy;
  • Concomitant serious complications, including end-stage lung disease, unstable coronary heart disease or congestive heart failure grade 3-4, chronic kidney disease stage 4-5, cirrhosis (Child-Pugh) grade C, immunodeficiency;
  • Incomplete data records.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital，College of Medicine，Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Prospective Study of Early Warning and Predictive Indicators Related to the Individualized Staging and Prognosis in Liver Cancer Patients

Liver cancer is one of the most common malignant tumors worldwide with high morbidity and mortality, and hepatocellular carcinoma (HCC) is the main histological subtype. So far, liver resection is the most effective treatment but the postoperative recurrence rate is high at five years, and the prognosis is difficult to estimate. Microvascular invasion (MVI) and postoperative minimal residual disease (MRD) are crucial prognostic factors for patients undergoing hepatectomy. Although many laboratory and imaging methods have been established to estimate the recurrence risk, their stability and accuracy are still not high. To date, no unified conclusion is achieved. It's eagerly to screen out a batch of individualized staging and prognosis-related biological indicators for early warning and prediction of prognosis, having good stability and high precision. Circulating cell-free DNA (cfDNA) molecular detection technology is an emerging detection technology of tumor gene profiling in recent years, which can be used to predict and monitor tumor recurrence. In this study, by detecting genomic chromosomal abnormalities in plasma and tumor tissues of patients before and after surgery, the investigators hope to construct a preoperative MVI prediction model and a postoperative MRD monitoring model, so as to provide reference for the precise treatment of HCC.

Read the detailed description

MVI and MRD confirmed by postoperative pathology are important prognostic factors for recurrence after liver resection, but current assessment methods have low sensitivity and specificity. cfDNA refers to the partially degraded endogenous DNA in the circulating blood that is free from the extracellular part of the body. When derived from dead and lysed tumor cells, it is called ctDNA, having a high chromosomal instability and relating to the tumor subtype and process. By low coverage whole genome sequencing, cfDNA and ctDNA in plasma were extracted and sequenced and chromosomal instability analysis is realized through UCAD pipeline. Therefore, the investigators can predict the trend of tumor by detecting cfDNA in patients, indicate MVI and MRD, carry out individualized staging of patients, predict recurrence and prognosis, and verify the prediction efficiency through follow-up, so as to establish corresponding prediction models.

Being tested
Liver resection method
Keywords
microvascular invasion, minimal residual disease, circulating cell-free DNA, chromosomal abnormalities
Medical subject headings
Carcinoma, Hepatocellular, Neoplasm, Residual, Chromosome Aberrations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver resection methodProcedure or surgery

    undergo anatomical or non-anatomical resection of liver cancer

Study groups in NCT05371873
Study groupRoleWhat they receive
Anatomical resection groupAnatomical resection of liver cancer tissue
Receives: Procedure: Liver resection method
Non-anatomical resection groupNon-anatomical resection of liver cancer tissue
Receives: Procedure: Liver resection method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MVI model

    Establish a preoperative prediction model of MVI by detecting chromosomal abnormalities in peripheral blood cfDNA

    Measured: 4 years

  2. MRD monitor

    Monitor postoperative MRD in postoperative patients and predict the recurrence risk and prognosis by detecting chromosomal abnormalities in peripheral blood cfDNA.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371873
Sponsor's protocol ID
HCCpredictor
Status last verified
Sep 2023
First submitted
8 May 2022
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heimbach JK, Kulik LM, Finn RS, Sirlin CB, Abecassis MM, Roberts LR, Zhu AX, Murad MH, Marrero JA. AASLD guidelines for the treatment of hepatocellular carcinoma. Hepatology. 2018 Jan;67(1):358-380. doi: 10.1002/hep.29086. No abstract available.

    PubMed 28130846

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available.

    PubMed 29628281

  • Imamura H, Matsuyama Y, Tanaka E, Ohkubo T, Hasegawa K, Miyagawa S, Sugawara Y, Minagawa M, Takayama T, Kawasaki S, Makuuchi M. Risk factors contributing to early and late phase intrahepatic recurrence of hepatocellular carcinoma after hepatectomy. J Hepatol. 2003 Feb;38(2):200-7. doi: 10.1016/s0168-8278(02)00360-4.

    PubMed 12547409

  • Pote N, Cauchy F, Albuquerque M, Voitot H, Belghiti J, Castera L, Puy H, Bedossa P, Paradis V. Performance of PIVKA-II for early hepatocellular carcinoma diagnosis and prediction of microvascular invasion. J Hepatol. 2015 Apr;62(4):848-54. doi: 10.1016/j.jhep.2014.11.005. Epub 2014 Nov 11.

    PubMed 25450201

  • Ye Q, Ling S, Zheng S, Xu X. Liquid biopsy in hepatocellular carcinoma: circulating tumor cells and circulating tumor DNA. Mol Cancer. 2019 Jul 3;18(1):114. doi: 10.1186/s12943-019-1043-x.

    PubMed 31269959

  • Wang D, Xu Y, Goldstein JB, Ye K, Hu X, Xiao L, Li L, Chang L, Guan Y, Long G, He Q, Yi X, Zhang J, Wang Z, Xia X, Zhou L. Preoperative evaluation of microvascular invasion with circulating tumour DNA in operable hepatocellular carcinoma. Liver Int. 2020 Aug;40(8):1997-2007. doi: 10.1111/liv.14463. Epub 2020 May 23.

    PubMed 32279416

  • Shu Z, Ye T, Wu W, Su M, Wang J, Zhang M, Qian Z, Huang H, Zheng S, Xia Q. Preoperative plasma cell-free DNA chromosomal instability predicts microvascular invasion in hepatocellular carcinoma: a prospective study. BMC Cancer. 2025 May 13;25(1):867. doi: 10.1186/s12885-025-14268-9.

    PubMed 40361115

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MVI model (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05371873, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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