Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT05257694
Status:
RECRUITING
Last Update Posted:
2022-10-21
First Post:
2022-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2022-02-13', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free survival (RFS)', 'timeFrame': 'Immediately after the surgery or ablation', 'description': 'Recurrence-free survival is defined as the time elapsed between a predefined point in time (the date of diagnosis, randomization or the intervention) and any recurrence (local, regional, or distant) or death due to any cause (death is an event).'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': 'Immediately after the surgery or ablation', 'description': 'Recurrence included local tumor progression, regional recurrence, or distant recurrence.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'Contrast-enhanced Ultrasound', 'Prognosis', 'Surgery', 'Ablation']}, 'descriptionModule': {'briefSummary': 'Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions', 'detailedDescription': 'Collecting CEUS and clinical data of HCC from different institutions retrospectively.\n\nDeveloping a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients.\n\nThen, validating the deep learning model in the prospective data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with HCC corresponding to Ia, Ib, IIa stage (China liver cancer staging) who undergo resection or ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation\n* without macro-vascular invasion\n* Child-Pugh A/B grade\n* HCC is proved by pathological examination or two enhanced imaging\n* CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation\n* Invasive biomarker or prognosis of HCC available\n* CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)\n\nExclusion Criteria:\n\n* postop follow-up loss or expired less than 3 months\n* patients with co-malignancy\n* poor images quality for analyzing'}, 'identificationModule': {'nctId': 'NCT05257694', 'briefTitle': 'Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'A Deep Learning Model Based on Contrast-enhanced Ultrasound to Aid Clinical Decisions and Predict Biological Biomarker and Prognosis of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'S2022-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'hepatectomy'}, {'name': 'Ablation (Microwave ablation or Radiofrequency ablation)', 'type': 'PROCEDURE', 'description': 'image-guided ablation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Liang, Doctor', 'role': 'CONTACT'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ping Liang, Dr.', 'role': 'CONTACT', 'email': 'liangping301@hotmail.com', 'phone': '+86 10 66939530'}, {'name': 'jiapeng wu, Dr.', 'role': 'CONTACT', 'email': 'wjpdabao@126.com', 'phone': '+86 13079692188'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ping Liang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of department of interventional ultrasound', 'investigatorFullName': 'Ping Liang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}