Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-25 @ 3:02 PM
Study NCT ID:
NCT04459468
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2020-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004998', 'term': 'Ethiodized Oil'}], 'ancestors': [{'id': 'D007459', 'term': 'Iodized Oil'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Pre and Post-treatment procedure blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2020-07-01', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients', 'timeFrame': '2 years', 'description': 'X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP.'}], 'secondaryOutcomes': [{'measure': 'Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.', 'timeFrame': '2 years', 'description': 'X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment (such as denovo ablation or Y90) and obtain blood samples pre and post treatment procedure for biomarker identification using bead based X-aptamer library. No intervention is planned.', 'detailedDescription': 'This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver cancer will be enrolled.\n\nThe approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol TACE, denovo ablation or Y90 using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post treatment.\n\nLipiodol TACE, denovo ablation, or Y90 will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent.\n2. Male or female aged 18-70years.\n3. Diagnosed with primary or metastatic liver cancer.\n4. Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care.\n\nExclusion Criteria:\n\nSubjects who have received chemotherapy, radiation or surgery for HCC.'}, 'identificationModule': {'nctId': 'NCT04459468', 'briefTitle': 'Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for Hepatocellular Carcinoma (HCC)', 'orgStudyIdInfo': {'id': 'STU-2019-1758'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC for Lipiodol TACE, denovo ablation, or Y90 radioembolization', 'description': 'These patients will receive standard of care Lipiodol TACE, denovo ablation, or Y90 radioembolization treatment. No research intervention is planned.', 'interventionNames': ['Drug: Lipiodol']}, {'label': 'Healthy controls', 'description': 'Healthy controls from public database'}, {'label': 'HCC patients', 'description': 'HCC patients will be used for biomarker validation.'}], 'interventions': [{'name': 'Lipiodol', 'type': 'DRUG', 'description': 'Lipiodol TACE procedure', 'armGroupLabels': ['HCC for Lipiodol TACE, denovo ablation, or Y90 radioembolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Claire Starcke, BS', 'role': 'CONTACT', 'email': 'Charlton.Starcke@UTSouthwestern.edu', 'phone': '214-648-8152'}, {'name': 'Anil Pillai, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Claire Starcke, BS', 'role': 'CONTACT', 'email': 'Charlton.Starcke@UTSouthwestern.edu', 'phone': '214-648-8152'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOC PROFESSOR - Radiology', 'investigatorFullName': 'Anil Pillai', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}