Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-31 @ 4:25 AM
Study NCT ID:
NCT04445532
Status:
UNKNOWN
Last Update Posted:
2023-07-07
First Post:
2020-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatobiliary Tumors Tissue Samples Acquisition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D013058', 'term': 'Mass Spectrometry'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D008745', 'term': 'Methylation'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D055601', 'term': 'Organic Chemistry Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue, blood, urine, feces, ascites, bile samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-05', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collected samples', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Collected normal tissue, tumor samples, blood, urine, feces, ascites, bile samples from patients with hepatobiliary cancers'}], 'secondaryOutcomes': [{'measure': 'Biomarkers of resectable disease-free recurrence (DFS) and overall survival (OS)', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'Biomarkers of evolution of tumors and discover specific diagnostic markers for hepatobiliary tumors', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'Biomarkers of the efficacy of target and immunotherapy for advanced hepatobiliary tumors', 'timeFrame': 'through study completion, an average of 5 years'}, {'measure': 'Multi-omics analysis to further type and find therapeutic targets', 'timeFrame': 'through study completion, an average of 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Cholangiocarcinoma', 'Gallbladder Cancer', 'Biliary Tract Cancer', 'Liver Cancer', 'Precancerous Condition', 'Benign Hepatobiliary Disease', 'Healthy, no Evidence of Disease']}, 'referencesModule': {'references': [{'pmid': '30970190', 'type': 'BACKGROUND', 'citation': 'Villanueva A. Hepatocellular Carcinoma. N Engl J Med. 2019 Apr 11;380(15):1450-1462. doi: 10.1056/NEJMra1713263. No abstract available.'}, {'pmid': '27095655', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29628281', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30319983', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30943423', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27664259', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25362482', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28622513', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30814741', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28622514', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26258846', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23295441', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21320499', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22824818', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23358969', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26483051', 'type': 'BACKGROUND', 'citation': 'Bridgewater J, Lopes A, Wasan H, Malka D, Jensen L, Okusaka T, Knox J, Wagner D, Cunningham D, Shannon J, Goldstein D, Moehler M, Bekaii-Saab T, McNamara MG, Valle JW. Prognostic factors for progression-free and overall survival in advanced biliary tract cancer. Ann Oncol. 2016 Jan;27(1):134-40. doi: 10.1093/annonc/mdv483. Epub 2015 Oct 19.'}, {'pmid': '30061739', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Montal R, Sia D, Finn RS. Molecular therapies and precision medicine for hepatocellular carcinoma. Nat Rev Clin Oncol. 2018 Oct;15(10):599-616. doi: 10.1038/s41571-018-0073-4.'}, {'pmid': '30755690', 'type': 'BACKGROUND', 'citation': 'Havel JJ, Chowell D, Chan TA. The evolving landscape of biomarkers for checkpoint inhibitor immunotherapy. Nat Rev Cancer. 2019 Mar;19(3):133-150. doi: 10.1038/s41568-019-0116-x.'}, {'pmid': '31790344', 'type': 'BACKGROUND', 'citation': 'Finn RS, Ryoo BY, Merle P, Kudo M, Bouattour M, Lim HY, Breder V, Edeline J, Chao Y, Ogasawara S, Yau T, Garrido M, Chan SL, Knox J, Daniele B, Ebbinghaus SW, Chen E, Siegel AB, Zhu AX, Cheng AL; KEYNOTE-240 investigators. Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2020 Jan 20;38(3):193-202. doi: 10.1200/JCO.19.01307. Epub 2019 Dec 2.'}, {'pmid': '31961766', 'type': 'BACKGROUND', 'citation': 'Taylor MH, Lee CH, Makker V, Rasco D, Dutcus CE, Wu J, Stepan DE, Shumaker RC, Motzer RJ. Phase IB/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid Tumors. J Clin Oncol. 2020 Apr 10;38(11):1154-1163. doi: 10.1200/JCO.19.01598. Epub 2020 Jan 21.'}, {'pmid': '30251463', 'type': 'BACKGROUND', 'citation': 'Sirica AE, Gores GJ, Groopman JD, Selaru FM, Strazzabosco M, Wei Wang X, Zhu AX. Intrahepatic Cholangiocarcinoma: Continuing Challenges and Translational Advances. Hepatology. 2019 Apr;69(4):1803-1815. doi: 10.1002/hep.30289. Epub 2019 Mar 25.'}, {'pmid': '31922567', 'type': 'BACKGROUND', 'citation': "Flaherty KT, Gray R, Chen A, Li S, Patton D, Hamilton SR, Williams PM, Mitchell EP, Iafrate AJ, Sklar J, Harris LN, McShane LM, Rubinstein LV, Sims DJ, Routbort M, Coffey B, Fu T, Zwiebel JA, Little RF, Marinucci D, Catalano R, Magnan R, Kibbe W, Weil C, Tricoli JV, Alexander B, Kumar S, Schwartz GK, Meric-Bernstam F, Lih CJ, McCaskill-Stevens W, Caimi P, Takebe N, Datta V, Arteaga CL, Abrams JS, Comis R, O'Dwyer PJ, Conley BA; NCI-MATCH Team. The Molecular Analysis for Therapy Choice (NCI-MATCH) Trial: Lessons for Genomic Trial Design. J Natl Cancer Inst. 2020 Oct 1;112(10):1021-1029. doi: 10.1093/jnci/djz245."}, {'pmid': '32045030', 'type': 'BACKGROUND', 'citation': 'Nault JC, Villanueva A. Biomarkers for Hepatobiliary Cancers. Hepatology. 2021 Jan;73 Suppl 1:115-127. doi: 10.1002/hep.31175. Epub 2020 Nov 29.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTherefore, 450 patients at least 18 years of age with hepatobiliary tumors were included in this study.', 'detailedDescription': 'OBJECTIVES:\n\n1. Observe the biomarkers of resectable hepatobiliary tumor recurrence (DFS) and survival (OS);\n2. Observe the evolution of tumors and discover specific diagnostic markers as a control group.\n3. Observe the response (ORR), progression (PFS) and survival (OS) biomarkers of targeted immunotherapy for advanced hepatobiliary tumors;\n4. To elaborate on the multi-omics study of hepatobiliary tumors, to further subtype and find therapeutic targets'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatobiliary cancer, benign hepatobiliary disease, and healthy Subjects will be recruited at Peking Union Medical College Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be older than 18 years old;\n2. ECOG 0-2 points;\n3. May have received treatment;\n4. Clinical consideration or diagnosis of benign and malignant hepatobiliary tumors; or chronic hepatitis, cirrhosis, or healthy control participants;\n5. Patients may have received or are about to undergo surgery, chemotherapy, radiotherapy, targeted therapy, local therapy, immunotherapy, etc.;\n6. Patients understand and are willing to sign written informed consent documents.\n\nExclusion Criteria:\n\n1. The doctor thinks it is not suitable to enter the group (mental disorder or poor compliance, etc.)\n2. Pregnant women;\n3. Active or uncontrollable infections (fungi, bacteria, etc.);\n4. Estimated survival time \\<12 weeks;\n5. If the patient is receiving chronic anticoagulant therapy, the anticoagulant withdrawal should not be shorter than 3 days;\n6. In the evaluation of the doctor, there is a risk of uncontrolled complications in the biopsy.'}, 'identificationModule': {'nctId': 'NCT04445532', 'briefTitle': 'Hepatobiliary Tumors Tissue Samples Acquisition', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors', 'orgStudyIdInfo': {'id': 'JS-2296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hepatobiliary tumor patients', 'description': 'benign or malignant hepatobiliary tumors patients', 'interventionNames': ['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']}, {'label': 'Benign Hepatobiliary Disease', 'description': 'chronic hepatitis, cirrhosis, and healthy control', 'interventionNames': ['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']}], 'interventions': [{'name': 'Gene expression analysis', 'type': 'OTHER', 'description': 'Gene expression analysis', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Genomic analysis', 'type': 'OTHER', 'description': 'Genomic analysis', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Protein expression analysis', 'type': 'OTHER', 'description': 'Protein expression analysis', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Proteomic profiling', 'type': 'OTHER', 'description': 'Proteomic profiling', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Polymerase chain reaction', 'type': 'OTHER', 'description': 'Polymerase chain reaction', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Mass spectrometry', 'type': 'OTHER', 'description': 'Mass spectrometry', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Immunohistochemistry', 'type': 'OTHER', 'description': 'Immunohistochemistry', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Metabolomics profiling', 'type': 'OTHER', 'description': 'Metabolomics profiling', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Methylation and epigenetic analysis', 'type': 'OTHER', 'description': 'Methylation and epigenetic analysis', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Liquid biopsy analysis', 'type': 'OTHER', 'description': 'Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}, {'name': 'Laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Laboratory biomarker analysis (such as AFP, CA19-9, CEA)', 'armGroupLabels': ['Benign Hepatobiliary Disease', 'hepatobiliary tumor patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xu Yang, MD', 'role': 'CONTACT', 'email': 'yangxulcyx@163.com', 'phone': '+86 158-1066-7683', 'phoneExt': '010-69156043'}, {'name': 'Haitao Zhao, MD', 'role': 'CONTACT', 'email': 'zhaoht@pumch.cn'}, {'name': 'Xiaobo Yang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chinese Academy of Medical Sciences & Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'XiaoBo Yang, MD', 'role': 'CONTACT', 'email': 'yangxiaobo67@pumch.cn', 'phone': '+86-138-1167-5126'}, {'name': 'Haitao Zhao, MD', 'role': 'CONTACT', 'email': 'zhaoht@pumch.cn'}], 'overallOfficials': [{'name': 'Haitao Zhao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'OrigiMed', 'class': 'INDUSTRY'}, {'name': 'GeneCast Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'YuceBio Technology Co., Ltd.', 'class': 'UNKNOWN'}, {'name': 'Geneplus-Beijing Co. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}