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

NCT ID: NCT05371873

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anatomical resection group

Anatomical resection of liver cancer tissue

Liver resection method

Intervention Type PROCEDURE

undergo anatomical or non-anatomical resection of liver cancer

Non-anatomical resection group

Non-anatomical resection of liver cancer tissue

Liver resection method

Intervention Type PROCEDURE

undergo anatomical or non-anatomical resection of liver cancer

Interventions

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Liver resection method

undergo anatomical or non-anatomical resection of liver cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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xiaqi

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Zhang, director

Role: STUDY_DIRECTOR

First Affiliated Hospital of Zhejiang University

Locations

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The First Affiliated Hospital,College of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 28130846 (View on PubMed)

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.

Reference Type RESULT
PMID: 29628281 (View on PubMed)

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.

Reference Type RESULT
PMID: 12547409 (View on PubMed)

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.

Reference Type RESULT
PMID: 25450201 (View on PubMed)

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.

Reference Type RESULT
PMID: 31269959 (View on PubMed)

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.

Reference Type RESULT
PMID: 32279416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40361115 (View on PubMed)

Other Identifiers

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HCCpredictor

Identifier Type: -

Identifier Source: org_study_id

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