Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-02-03 @ 12:12 AM
Study NCT ID:
NCT03110068
Status:
UNKNOWN
Last Update Posted:
2017-04-12
First Post:
2017-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], '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': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of microvascular invasion', 'timeFrame': 'Through patient enrollment completion, an average of 2 years', 'description': 'Postoperative histologically confirmed microvascular invasion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microvascular invasion', 'serum biomarker', 'radiological feature', 'pathological differentiation'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26579636', 'type': 'BACKGROUND', 'citation': 'Lei Z, Li J, Wu D, Xia Y, Wang Q, Si A, Wang K, Wan X, Lau WY, Wu M, Shen F. Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatitis B Virus-Related Hepatocellular Carcinoma Within the Milan Criteria. JAMA Surg. 2016 Apr;151(4):356-63. doi: 10.1001/jamasurg.2015.4257.'}, {'pmid': '28189206', 'type': 'BACKGROUND', 'citation': 'Zhao H, Hua Y, Dai T, He J, Tang M, Fu X, Mao L, Jin H, Qiu Y. Development and validation of a novel predictive scoring model for microvascular invasion in patients with hepatocellular carcinoma. Eur J Radiol. 2017 Mar;88:32-40. doi: 10.1016/j.ejrad.2016.12.030. Epub 2016 Dec 27.'}, {'pmid': '27743138', 'type': 'BACKGROUND', 'citation': 'Feng LH, Dong H, Lau WY, Yu H, Zhu YY, Zhao Y, Lin YX, Chen J, Wu MC, Cong WM. Novel microvascular invasion-based prognostic nomograms to predict survival outcomes in patients after R0 resection for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2017 Feb;143(2):293-303. doi: 10.1007/s00432-016-2286-1. Epub 2016 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'Presence of microvascular invasion can be estimated preoperatively, by some clinical imaging features such as patient characteristics, serum biomarkers and radiological features. Contrast-enhanced ultrasonography (CEUS) and contrast-enhanced computed tomography (CECT) are routine preoperative conventional examinations for hepatocellular carcinoma (HCC) patients in China. Combining features of CEUS, CECT and clinical factors may improve preoperative MVI assessment. The purpose of this study is to construct a nomogram for preoperative MVI risk estimation with these possible factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Between April 2017 and April 2019，all consecutive patients who will undergo curative resection (R0 resection) at the First Affiliated Hospital of Sun Yat-Sen University in Guangzhou, China, for HCC based on the modified WHO classification of tumors of the digestive system, are considered for inclusion. By the eligibility criteria stated below, MVI presentative rate is 30-42% in chinese HCC population as reported, and an estimated 400 patients will be needed for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asian patients aged 18～80 years old;\n* With no preoperative anti-cancer treatment;\n* Scheduled for radical liver resection;\n* With both CEUS and CECT performed in 4 weeks before surgery;\n* Postoperative histologically confirmed HCC;\n* With sufficient surgical specimen for MVI detection (surgical margin ≥1cm);\n\nExclusion Criteria:\n\n* Recurrent HCC or combined hepatocellular-cholangiocarcinoma;\n* With extra-hepatic metastasis or macrovascular invasion;\n* With incomplete clinical and imaging data;\n* Non-radical resection;'}, 'identificationModule': {'nctId': 'NCT03110068', 'briefTitle': 'Preoperative Estimation of Microvascular Invasion in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Nomogram for Preoperative Estimation of Microvascular Invasion Risk in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'SYSU01-US-201701'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative clinical/imaging features', 'description': 'In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo contrast-enhanced computed tomography (CECT) and contrast-enhanced ultrasound (CEUS).', 'interventionNames': ['Diagnostic Test: contrast-enhanced ultrasound', 'Diagnostic Test: contrast-enhanced computed tomography']}], 'interventions': [{'name': 'contrast-enhanced ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Aplio SSA-770A or Aplio 500 (Toshiba Medical Systems, Tokyo, Japan) equipped with a 375BT convex transducer (frequency range, 1.9 to 6.0 MHz). CHI is used with a mechanical index that ranged from 0.06 to 0.10. After activating CHI mode, a bolus injection of 2.4 ml of SonoVue (Bracco, Milan, Italy) is administered intravenously via an antecubital vein, followed immediately by a flush of 5 ml of normal saline solution. The targeted lesion should be observed continuously for 5 minutes, and the entire arterial and portal venous phases and several repetitions of the late phase are stored on the hard disk. The arterial, portal venous and late phases are defined as 0-30 s, 31-120 s and 121-360 s after the injection, respectively.', 'armGroupLabels': ['Preoperative clinical/imaging features']}, {'name': 'contrast-enhanced computed tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Aquilion 64-slice helical CT machine (Tokyo, Japan) is used. The imaging protocol for CT examinations is as follows: 0.5 mm × 64 mm collimation, 120 kV, 150-200 mAs for 64-slice helical CT examination. The standard triphasic scan procedure is used. An unenhanced helical sequence scan through the liver will be performed first; thereafter nonionic iodinated contrast material (Ultravist, Schering, Berlin, Germany) (1.5 mL/kg) will be administered via antecubital vein with power injection at a rate of 4 mL/s for 64-slice helical CT. The arterial phase sequence is obtained 25-32 s after contrast material administration, followed by a portal venous phase sequence 70 s after contrast agent administration.', 'armGroupLabels': ['Preoperative clinical/imaging features']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Wang, MD, PhD', 'role': 'CONTACT', 'email': 'wangw73@mail.sysu.edu.cn', 'phone': '+86 18218227118'}, {'name': 'Hang-Tong Hu, MD', 'role': 'CONTACT', 'email': 'huhangt@gmail.com', 'phone': '+86 13580313297'}], 'overallOfficials': [{'name': 'Ming Kuang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Medical Ultrasonics, Institute of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ming Kuang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ming Kuang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}