Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05393102
Status:
UNKNOWN
Last Update Posted:
2022-05-26
First Post:
2022-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures
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': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2022-05-08', 'studyFirstSubmitQcDate': '2022-05-24', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.', 'timeFrame': 'Enrollment of the first participant up to 18 months', 'description': 'Sensitivity is defined as the ratio of positively detected participants in all malignant nodule patients by cfDNA signatures.'}, {'measure': 'Specificity of the cfDNA whole-genome signatures based model in liver nodules diagnosis.', 'timeFrame': 'Enrollment of the first participant up to 18 months', 'description': 'Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by cfDNA signatures.'}], 'secondaryOutcomes': [{'measure': 'Specificity of the model that composed of cfDNA signatures, imaging examination，serum protein markers and clinical characteristics in liver nodules diagnosis.', 'timeFrame': 'Through study completion，an average of 18 months', 'description': 'Specificity is defined as the proportion of negatively detected participants in all benign liver nodules patients by the model that composed of cfDNA whole-genome signatures, imaging examination，serum protein markers， and clinical characteristics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatocellular carcinoma', 'liver nodules', 'auxiliary diagnosis', 'liquid biopsy', 'peripheral blood', 'cfDNA'], 'conditions': ['Focal Liver Lesions']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}, {'pmid': '16369988', 'type': 'BACKGROUND', 'citation': 'Kobayashi M, Ikeda K, Hosaka T, Sezaki H, Someya T, Akuta N, Suzuki F, Suzuki Y, Saitoh S, Arase Y, Kumada H. Dysplastic nodules frequently develop into hepatocellular carcinoma in patients with chronic viral hepatitis and cirrhosis. Cancer. 2006 Feb 1;106(3):636-47. doi: 10.1002/cncr.21607.'}, {'pmid': '17087938', 'type': 'BACKGROUND', 'citation': 'Llovet JM, Chen Y, Wurmbach E, Roayaie S, Fiel MI, Schwartz M, Thung SN, Khitrov G, Zhang W, Villanueva A, Battiston C, Mazzaferro V, Bruix J, Waxman S, Friedman SL. A molecular signature to discriminate dysplastic nodules from early hepatocellular carcinoma in HCV cirrhosis. Gastroenterology. 2006 Dec;131(6):1758-67. doi: 10.1053/j.gastro.2006.09.014. Epub 2006 Sep 19.'}, {'pmid': '33589745', 'type': 'BACKGROUND', 'citation': 'Chen L, Abou-Alfa GK, Zheng B, Liu JF, Bai J, Du LT, Qian YS, Fan R, Liu XL, Wu L, Hou JL, Wang HY; PreCar Team. Genome-scale profiling of circulating cell-free DNA signatures for early detection of hepatocellular carcinoma in cirrhotic patients. Cell Res. 2021 May;31(5):589-592. doi: 10.1038/s41422-020-00457-7. Epub 2021 Feb 15. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'As a prospective, multi-center study, GUIDER will recruit 400 liver nodules participants from different provinces and regions across China. Except for cfDNA signatures, serum biomarkers, histopathological biopsy and enhanced MRI will also be performed. The sensitivity and specificity of the cfDNA signature based-model in liver nodules diagnosing will be evaluated.', 'detailedDescription': 'Patients with liver nodules will be recruited for 1 year. Peripheral blood samples of all participants will be collected after being informed about the study and potential risks. CfDNA extraction, library construction, and whole genome sequencing will be performed. A machine learning method will be implemented for cfDNA signatures-based model construction at the end of the study. Sensitivity and specificity will be used to evaluate the performance of cfDNA signatures-based model in liver nodules diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four hundreds eligible participants will be recruited from medical centers and assigned into three groups, including participants with malignant or benign liver nodules，and participants with uncertain liver nodules.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eighteen years or elder；\n* Participants underwent enhanced MRI for the evaluation of liver nodules ≤5 cm；\n* Participants whose platelet count ≥ 50×109/L, prothrombin activity (PTA) ≥ 60%；\n* Participants who are willing and able to perform hepatectomy or tissure biopsy.\n\nExclusion Criteria:\n\n* Participants with different enhancement mode liver nodules that detected by enhanced MRI and without CEUS confirmation；\n* Diagnosis of malignant tumors before recruitment；\n* Anti-tumor therapy before recruitment ；\n* HIV infection；\n* Pregnancy；\n* Allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection;\n* Participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage.\n* Participants with any other factors that may leading to termination of the study.'}, 'identificationModule': {'nctId': 'NCT05393102', 'acronym': 'GUIDER', 'briefTitle': 'Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome Signatures', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Auxiliary Diagnosis of Liver Nodules Using cfDNA Whole-genome SignatuRes (GUDIER): an Observational Cohort Trial', 'orgStudyIdInfo': {'id': '2022-20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malignant liver nodules cohort', 'description': 'Participants with malignant liver nodules diagnosed by pathological biopsy.', 'interventionNames': ['Other: No interventions']}, {'label': 'Benign liver nodules cohort', 'description': 'Participants with benign liver nodules diagnosed by pathological biopsy or imaging examination.', 'interventionNames': ['Other: No interventions']}, {'label': 'Uncertain benign or malignant liver nodules cohort', 'description': 'Participants with liver nodules could not be diagnosed definitely by imaging examination and serum protein markers.', 'interventionNames': ['Other: No interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'description': 'No interventions', 'armGroupLabels': ['Benign liver nodules cohort', 'Malignant liver nodules cohort', 'Uncertain benign or malignant liver nodules cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400010', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The 2nd affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Jinlin Hou, MD', 'role': 'CONTACT', 'email': 'jlhousmu@163.com', 'phone': '13802727354'}], 'facility': 'Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '200438', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Hongyang Wang, MD', 'role': 'CONTACT', 'email': 'hywangk@vip.sina.com', 'phone': '86 21 81875361'}, {'name': 'Lei Chen, MD', 'role': 'CONTACT', 'email': 'chenlei@smmu.edu.cn', 'phone': '86 13918939969'}], 'facility': 'Eastern Hepatobiliary Surgery Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hong Ren, MD', 'role': 'CONTACT', 'email': 'renhong0531@vip.sina.com.cn', 'phone': '13983888786'}], 'overallOfficials': [{'name': 'Hong Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}, {'name': 'Hongyang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospita'}, {'name': 'Jinlin Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hong Ren', 'investigatorAffiliation': 'The Second Affiliated Hospital of Chongqing Medical University'}}}}