Prognostic Value of Liver Cancer CTCs Isolated by a Novel Microfluidic Platform

NCT05242237 | Unknown

• 1 other identifier: HCC-CTC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to isolate CTCs in peripheral venous blood of liver cancer patients by inertial focusing principle-based microfluidic device, determine the relationship between the number of CTCs and patient prognosis and treatment response, detect mutation, copy number variation and mutation load in CTC cells and corresponding tissues using single-cell whole genome sequencing technology, and use bioinformatics analysis of CTC heterogeneity and its relationship with clinical outcome. In addition, the culture of CTCs in vitro was explored by organoid culture or sphere culture in order to obtain CTCs cell lines to reveal the metastatic mechanisms of HCC. The partner of this project is Cellomics International Limited, which could provide Cellomics CTC-100 cell sorter and related consumables for this project. Peripheral venous blood from about 300 patients with initial liver cancer will be collected, and CTCs cells will be sorted in 8ml of each patient and typed according to protein expression. Clinical data, treatment effect and survival time of patients will be collected, and finally the relationship between the number of CTCs and subgroup with treatment response and patient prognosis will be analyzed. Uncovering the genomic characteristics of CTCs of HCC provides a new basis for the precise treatment of HCC. The new diagnostic markers for Hcancer were found by miRNA expression spectrum chip and metabolomic testing.In vitro culture methods and cellular characteristics of HCC circulating tumor cells were preliminarily explored.

Conditions

Hepatocellular Carcinoma; Circulating Tumor Cell; Whole Genome Sequencing

Keywords

whole genome sequencing; microfluidic device; inertial focus

Outcome Measures

Primary Outcomes (1)

• Time to progression or death (months)

  Time to progression or death (months) after initial diagnosis will be recorded.

  2 years

Study Arms (2)

HCC patients

HCC patients with initial diagnosis

Liver cirrhosis patients

Liver cirrhosis patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peripheral venous blood samples are expected to collect 300 liver cancer patients and 50 patients with liver cirrhosis, taking 8ml of venous blood from each patient. Among them, about 100 patients underwent surgery (about 5 \* 5 \* 5mm).After receiving follow-up for 1-2 years, information on patient treatment regimen, treatment response, recurrence, metastasis, survival time and other patients was collected.

You may qualify if:

• confirmed by imaging and serological examination for benign liver cancer;
• patients without any previous treatment;
• informed consent;
• age: 18 years or older (adult).

You may not qualify if:

• with other malignancies;
• metastatic liver tumors;
• with major organic lesions;
• with acute complications such as acute liver failure, massive gastrointestinal bleeding and so on.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead
• Cellomics International Limited: collaborator

Study Sites (1)

the second affiliated hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Related Publications (9)

• Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3.

  PMID: 33479224 RESULT

• Ahn JC, Teng PC, Chen PJ, Posadas E, Tseng HR, Lu SC, Yang JD. Detection of Circulating Tumor Cells and Their Implications as a Biomarker for Diagnosis, Prognostication, and Therapeutic Monitoring in Hepatocellular Carcinoma. Hepatology. 2021 Jan;73(1):422-436. doi: 10.1002/hep.31165. Epub 2021 Jan 18.

  PMID: 32017145 RESULT

• Chen VL, Xu D, Wicha MS, Lok AS, Parikh ND. Utility of Liquid Biopsy Analysis in Detection of Hepatocellular Carcinoma, Determination of Prognosis, and Disease Monitoring: A Systematic Review. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2879-2902.e9. doi: 10.1016/j.cgh.2020.04.019. Epub 2020 Apr 11.

  PMID: 32289533 RESULT

• Zhu Z, Qiu S, Shao K, Hou Y. Progress and challenges of sequencing and analyzing circulating tumor cells. Cell Biol Toxicol. 2018 Oct;34(5):405-415. doi: 10.1007/s10565-017-9418-5. Epub 2017 Nov 22.

  PMID: 29168077 RESULT

• Court CM, Hou S, Liu L, Winograd P, DiPardo BJ, Liu SX, Chen PJ, Zhu Y, Smalley M, Zhang R, Sadeghi S, Finn RS, Kaldas FM, Busuttil RW, Zhou XJ, Tseng HR, Tomlinson JS, Graeber TG, Agopian VG. Somatic copy number profiling from hepatocellular carcinoma circulating tumor cells. NPJ Precis Oncol. 2020 Jul 2;4:16. doi: 10.1038/s41698-020-0123-0. eCollection 2020.

  PMID: 32637655 RESULT

• Pantel K, Hille C, Scher HI. Circulating Tumor Cells in Prostate Cancer: From Discovery to Clinical Utility. Clin Chem. 2019 Jan;65(1):87-99. doi: 10.1373/clinchem.2018.287102.

  PMID: 30602476 RESULT

• Chen W, Zhang J, Huang L, Chen L, Zhou Y, Tang D, Xie Y, Wang H, Huang C. Detection of HER2-positive Circulating Tumor Cells Using the LiquidBiopsy System in Breast Cancer. Clin Breast Cancer. 2019 Feb;19(1):e239-e246. doi: 10.1016/j.clbc.2018.10.009. Epub 2018 Nov 1.

  PMID: 30472074 RESULT

• Wang PX, Sun YF, Zhou KQ, Cheng JW, Hu B, Guo W, Yin Y, Huang JF, Zhou J, Fan J, Cheung TT, Qu XD, Yang XR. Circulating tumor cells are an indicator for the administration of adjuvant transarterial chemoembolization in hepatocellular carcinoma: A single-center, retrospective, propensity-matched study. Clin Transl Med. 2020 Jul;10(3):e137. doi: 10.1002/ctm2.137. Epub 2020 Jul 23.

  PMID: 32702202 RESULT

• Jackson JM, Witek MA, Kamande JW, Soper SA. Materials and microfluidics: enabling the efficient isolation and analysis of circulating tumour cells. Chem Soc Rev. 2017 Jul 17;46(14):4245-4280. doi: 10.1039/c7cs00016b.

  PMID: 28632258 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ZHOU ZHIHANG

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZHOU ZHIHANG

CONTACT

86-17815183428; zhouzhihang@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 16, 2022
• Study Start: December 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: will be shared after the trial has been finished

Locations

CN (1)