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Hepatocellular CarcinomaNCT04445532

Hepatobiliary Tumors Tissue Samples Acquisition

An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by Peking Union Medical College Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Gene expression analysis, Genomic analysis and Protein expression analysis
How many people
450 participants
Where
1 siteChina
Study dates
11 Oct 2020to 1 Jun 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited at Peking Union Medical College Hospital.

Who may be able to join

  • Be older than 18 years old;
  • ECOG 0-2 points;
  • May have received treatment;
  • Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants;
  • Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;
  • Patients understand and are willing to sign written informed consent documents.

Who cannot join

  • The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.)
  • Pregnant women;
  • Active or uncontrollable infections (fungi, bacteria, etc.);
  • Estimated survival time <12 weeks;
  • If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days;
  • In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.

Trial locations and contacts

1 site in 1 country.

XiaoBo Yang, MD contact

+86-138-1167-5126

yangxiaobo67@pumch.cn

Haitao Zhao, MD contact

zhaoht@pumch.cn

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Xu Yang, MD, +86 158-1066-7683 ext. 010-69156043, yangxulcyx@163.com

    Haitao Zhao, MD, zhaoht@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors

Hepatobiliary tumors have a poor prognosis and high individual heterogeneity, so it is of great significance to find important prognostic markers and then screen out specific subgroups of people; meanwhile, chronic hepatitis, cirrhosis, and healthy control participants also need to show the evolution of tumors and discover specific diagnostic markers as a control group. Moreover, targeted therapy and immunotherapy make cancer treatment enter a new field, but only part of patients achieve response rates and reach clinical benefit. However, these drugs are expensive and can cause treatment-related adverse events. Therefore, reliable biomarkers identification is needed to help predict the response to these treatment options in order to screen patients with better responsiveness and avoid wasting money. Multi-omics research can reveal the characteristics of hepatobiliary tumors more deeply and find meaningful therapeutic targets.

Therefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.

Read the detailed description

OBJECTIVES:

  1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);
  2. Observe the evolution of tumors and discover specific diagnostic markers as a control group.
  3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;
  4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets
Being tested
Gene expression analysis, Genomic analysis, Protein expression analysis, Proteomic profiling, Polymerase chain reaction
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma, Gallbladder Neoplasms, Biliary Tract Neoplasms, Liver Neoplasms, Precancerous Conditions

What participants receive

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

  • Gene expression analysisOther

    Gene expression analysis

  • Genomic analysisOther

    Genomic analysis

  • Protein expression analysisOther

    Protein expression analysis

  • Proteomic profilingOther

    Proteomic profiling

  • Polymerase chain reactionOther

    Polymerase chain reaction

  • Mass spectrometryOther

    Mass spectrometry

  • ImmunohistochemistryOther

    Immunohistochemistry

  • Metabolomics profilingOther

    Metabolomics profiling

  • Methylation and epigenetic analysisOther

    Methylation and epigenetic analysis

  • Liquid biopsy analysisOther

    Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis

  • Laboratory biomarker analysisOther

    Laboratory biomarker analysis (such as AFP, CA19-9, CEA)

Study groups in NCT04445532
Study groupRoleWhat they receive
hepatobiliary tumor patientsbenign or malignant hepatobiliary tumors patients
Receives: Other: Gene expression analysis; Other: Genomic analysis; Other: Protein expression analysis; Other: Proteomic profiling; Other: Polymerase chain reaction; Other: Mass spectrometry; Other: Immunohistochemistry; Other: Metabolomics profiling; Other: Methylation and epigenetic analysis; Other: Liquid biopsy analysis; Other: Laboratory biomarker analysis
Benign Hepatobiliary Diseasechronic hepatitis, cirrhosis, and healthy control
Receives: Other: Gene expression analysis; Other: Genomic analysis; Other: Protein expression analysis; Other: Proteomic profiling; Other: Polymerase chain reaction; Other: Mass spectrometry; Other: Immunohistochemistry; Other: Metabolomics profiling; Other: Methylation and epigenetic analysis; Other: Liquid biopsy analysis; Other: Laboratory biomarker analysis

What is being measured

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

  1. Collected samples

    Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers

    Measured: through study completion, an average of 5 years

Secondary outcomes (4)

  1. Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)

    Measured: through study completion, an average of 5 years

  2. Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors

    Measured: through study completion, an average of 5 years

  3. Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors

    Measured: through study completion, an average of 5 years

  4. Multi-omics analysis to further type and find therapeutic targets

    Measured: through study completion, an average of 5 years

Timeline

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

  1. First posted24 Jun 2020
  2. Study start11 Oct 2020
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 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
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04445532
Sponsor's protocol ID
JS-2296
Status last verified
Mar 2023
First submitted
18 Jun 2020
Last updated
7 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.

    PubMed 30970190

  • Banales JM, Cardinale V, Carpino G, Marzioni M, Andersen JB, Invernizzi P, Lind GE, Folseraas T, Forbes SJ, Fouassier L, Geier A, Calvisi DF, Mertens JC, Trauner M, Benedetti A, Maroni L, Vaquero J, Macias RI, Raggi C, Perugorria MJ, Gaudio E, Boberg KM, Marin JJ, Alvaro D. Expert consensus document: Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol. 2016 May;13(5):261-80. doi: 10.1038/nrgastro.2016.51. Epub 2016 Apr 20.

    PubMed 27095655

  • 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

  • Zhou J, Sun HC, Wang Z, Cong WM, Wang JH, Zeng MS, Yang JM, Bie P, Liu LX, Wen TF, Han GH, Wang MQ, Liu RB, Lu LG, Ren ZG, Chen MS, Zeng ZC, Liang P, Liang CH, Chen M, Yan FH, Wang WP, Ji Y, Cheng WW, Dai CL, Jia WD, Li YM, Li YX, Liang J, Liu TS, Lv GY, Mao YL, Ren WX, Shi HC, Wang WT, Wang XY, Xing BC, Xu JM, Yang JY, Yang YF, Ye SL, Yin ZY, Zhang BH, Zhang SJ, Zhou WP, Zhu JY, Liu R, Shi YH, Xiao YS, Dai Z, Teng GJ, Cai JQ, Wang WL, Dong JH, Li Q, Shen F, Qin SK, Fan J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2017 Edition). Liver Cancer. 2018 Sep;7(3):235-260. doi: 10.1159/000488035. Epub 2018 Jun 14.

    PubMed 30319983

  • Llovet JM, Montal R, Villanueva A. Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival. J Hepatol. 2019 Jun;70(6):1262-1277. doi: 10.1016/j.jhep.2019.01.028. Epub 2019 Mar 31.

    PubMed 30943423

  • Valle JW, Borbath I, Khan SA, Huguet F, Gruenberger T, Arnold D; ESMO Guidelines Committee. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. doi: 10.1093/annonc/mdw324. No abstract available.

    PubMed 27664259

  • Totoki Y, Tatsuno K, Covington KR, Ueda H, Creighton CJ, Kato M, Tsuji S, Donehower LA, Slagle BL, Nakamura H, Yamamoto S, Shinbrot E, Hama N, Lehmkuhl M, Hosoda F, Arai Y, Walker K, Dahdouli M, Gotoh K, Nagae G, Gingras MC, Muzny DM, Ojima H, Shimada K, Midorikawa Y, Goss JA, Cotton R, Hayashi A, Shibahara J, Ishikawa S, Guiteau J, Tanaka M, Urushidate T, Ohashi S, Okada N, Doddapaneni H, Wang M, Zhu Y, Dinh H, Okusaka T, Kokudo N, Kosuge T, Takayama T, Fukayama M, Gibbs RA, Wheeler DA, Aburatani H, Shibata T. Trans-ancestry mutational landscape of hepatocellular carcinoma genomes. Nat Genet. 2014 Dec;46(12):1267-73. doi: 10.1038/ng.3126. Epub 2014 Nov 2.

    PubMed 25362482

  • Cancer Genome Atlas Research Network. Electronic address: wheeler@bcm.edu; Cancer Genome Atlas Research Network. Comprehensive and Integrative Genomic Characterization of Hepatocellular Carcinoma. Cell. 2017 Jun 15;169(7):1327-1341.e23. doi: 10.1016/j.cell.2017.05.046.

    PubMed 28622513

  • Jiang Y, Sun A, Zhao Y, Ying W, Sun H, Yang X, Xing B, Sun W, Ren L, Hu B, Li C, Zhang L, Qin G, Zhang M, Chen N, Zhang M, Huang Y, Zhou J, Zhao Y, Liu M, Zhu X, Qiu Y, Sun Y, Huang C, Yan M, Wang M, Liu W, Tian F, Xu H, Zhou J, Wu Z, Shi T, Zhu W, Qin J, Xie L, Fan J, Qian X, He F; Chinese Human Proteome Project (CNHPP) Consortium. Proteomics identifies new therapeutic targets of early-stage hepatocellular carcinoma. Nature. 2019 Mar;567(7747):257-261. doi: 10.1038/s41586-019-0987-8. Epub 2019 Feb 27.

    PubMed 30814741

  • Zheng C, Zheng L, Yoo JK, Guo H, Zhang Y, Guo X, Kang B, Hu R, Huang JY, Zhang Q, Liu Z, Dong M, Hu X, Ouyang W, Peng J, Zhang Z. Landscape of Infiltrating T Cells in Liver Cancer Revealed by Single-Cell Sequencing. Cell. 2017 Jun 15;169(7):1342-1356.e16. doi: 10.1016/j.cell.2017.05.035.

    PubMed 28622514

  • Nakamura H, Arai Y, Totoki Y, Shirota T, Elzawahry A, Kato M, Hama N, Hosoda F, Urushidate T, Ohashi S, Hiraoka N, Ojima H, Shimada K, Okusaka T, Kosuge T, Miyagawa S, Shibata T. Genomic spectra of biliary tract cancer. Nat Genet. 2015 Sep;47(9):1003-10. doi: 10.1038/ng.3375. Epub 2015 Aug 10.

    PubMed 26258846

  • Sia D, Hoshida Y, Villanueva A, Roayaie S, Ferrer J, Tabak B, Peix J, Sole M, Tovar V, Alsinet C, Cornella H, Klotzle B, Fan JB, Cotsoglou C, Thung SN, Fuster J, Waxman S, Garcia-Valdecasas JC, Bruix J, Schwartz ME, Beroukhim R, Mazzaferro V, Llovet JM. Integrative molecular analysis of intrahepatic cholangiocarcinoma reveals 2 classes that have different outcomes. Gastroenterology. 2013 Apr;144(4):829-40. doi: 10.1053/j.gastro.2013.01.001. Epub 2013 Jan 4.

    PubMed 23295441

  • Villanueva A, Hoshida Y, Battiston C, Tovar V, Sia D, Alsinet C, Cornella H, Liberzon A, Kobayashi M, Kumada H, Thung SN, Bruix J, Newell P, April C, Fan JB, Roayaie S, Mazzaferro V, Schwartz ME, Llovet JM. Combining clinical, pathology, and gene expression data to predict recurrence of hepatocellular carcinoma. Gastroenterology. 2011 May;140(5):1501-12.e2. doi: 10.1053/j.gastro.2011.02.006. Epub 2011 Feb 12.

    PubMed 21320499

  • Toyoda H, Kumada T, Tada T, Niinomi T, Ito T, Kaneoka Y, Maeda A. Prognostic significance of a combination of pre- and post-treatment tumor markers for hepatocellular carcinoma curatively treated with hepatectomy. J Hepatol. 2012 Dec;57(6):1251-7. doi: 10.1016/j.jhep.2012.07.018. Epub 2012 Jul 20.

    PubMed 22824818

  • Wang Y, Li J, Xia Y, Gong R, Wang K, Yan Z, Wan X, Liu G, Wu D, Shi L, Lau W, Wu M, Shen F. Prognostic nomogram for intrahepatic cholangiocarcinoma after partial hepatectomy. J Clin Oncol. 2013 Mar 20;31(9):1188-95. doi: 10.1200/JCO.2012.41.5984. Epub 2013 Jan 28.

    PubMed 23358969

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma and Cholangiocarcinoma, run by Peking Union Medical College Hospital 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 6 inclusion and 6 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 7 Jul 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?

Contact XiaoBo Yang, MD (+86-138-1167-5126, yangxiaobo67@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collected samples (time frame: through study completion, an average of 5 years). 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 NCT04445532, which also lists 23 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 7 Jul 2023.

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