Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05764551
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application of Serum DNA Methylation for Patients With HCC
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between serum DNA methylation and HCC recurrence or treatment response', 'timeFrame': '96 weeks', 'description': 'The correlation between serum DNA methylation and HCC recurrence or treatment response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DNA methylation'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'The goal of this single-arm prospective study is to evaluate the application of serum DNA methylation for HCC patients with normal alpha-fetoprotein. The main question it aims to answer is\n\n. Is the dynamic change of serum DNA methylation correlated to recurrence or treatment response of HCC', 'detailedDescription': 'The enrolled individuals with HCC and normal serum alpha-fetoprotein level would receive serum DNA methylation test before their treatment (including all kinds of recommened HCC treatment). Then regularly serum DNA methylation test would be done at 4th\\~8th weeks, 16th week, 32th week and 48th week. If the enrolled patients did not have HCC recurrence during at 48th week. The regular check of serum DNA methylation would be canceled. The enrolled patients would be observed till 96th week. If there is any recurrence during 48\\~96th week, one time of serum DNA methylation would be checked at the time of recurrence. The observation and intervention would be completed at 96th week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 20 years old\n* The diagnosis of hepatocellular carcinoma (HCC) according to AASLD 2018 clinical guidelines or histology report\n* Individuals with HCC and normal serum alpha-fetorpotein level (\\<20 ng/ml)\n* Individuals who could sign informed consent\n\nExclusion Criteria:\n\n* The histology report revealed non-HCC, HCC mixed with cholangiocarcinoma or sarcomatoid HCC\n* Individuals with HCC and other concurrent malignancies\n* Individuals with chronic kidney disease who could not tolerate contrast-enhanced dynamic images\n* Individuals ever receiving any organ transplantation\n* Individuals with HIV infection\n* Individuals who could not able to understand and sign informed consent'}, 'identificationModule': {'nctId': 'NCT05764551', 'briefTitle': 'The Application of Serum DNA Methylation for Patients With HCC', 'organization': {'class': 'OTHER', 'fullName': 'Chiayi Christian Hospital'}, 'officialTitle': 'he Application of DNA Methylation for Patients Who Had Hepatocellular Carcinoma With Normal Serum Alpha-fetoprotein', 'orgStudyIdInfo': {'id': 'IRB2022051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DNA methylation', 'description': 'The enrolled individuals with HCC would receive serum DNA methylation test before their treatment (including all kinds of recommened HCC treatment). Then regularly serum DNA methylation test would be done at 4th\\~8th weeks, 16th week, 32th week and 48th week. If the enrolled patients did not have HCC recurrence during at 48th week. The regular check of serum DNA methylation would be canceled. The enrolled patients would be observed till 96th week. If there is any recurrence during 48\\~96th week, one time of serum DNA methylation would be checked at the time of recurrence. The observation and intervention would be completed at 96th week.', 'interventionNames': ['Diagnostic Test: Serum DNA methylation']}], 'interventions': [{'name': 'Serum DNA methylation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum DNA methylation', 'armGroupLabels': ['DNA methylation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600', 'city': 'Chiayi City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Po-Yueh Chen, MD', 'role': 'CONTACT', 'email': 'hdilwy7@gmail.com', 'phone': '+8862765041', 'phoneExt': '5275'}, {'name': 'Po-Yueh Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chi-Yi Chen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chu-Kuang Chou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ditmanson Medical Foundation Chiayi Christian Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}], 'centralContacts': [{'name': 'Po-Yueh Chen, M.D', 'role': 'CONTACT', 'email': 'hdilwy7@gmail.com', 'phone': '+886-5-2765041', 'phoneExt': '5275'}, {'name': 'Chia-Yi Chen, M.D', 'role': 'CONTACT', 'email': 'cych12497@gmail.com', 'phone': '+886-5-2765041', 'phoneExt': '8636'}], 'overallOfficials': [{'name': 'Po-Yueh Chen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ditmanson Medical Foundation Chiayi Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiayi Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}