Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT06272656
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-06', 'releaseDate': '2025-02-16'}, {'resetDate': '2025-04-29', 'releaseDate': '2025-04-14'}], 'estimatedResultsFirstSubmitDate': '2025-02-16'}}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-25', 'size': 258859, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_000.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2024-02-02T21:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum samples from liver cancer patients at 4 ℃, 4000g, centrifuge for 10 minutes, and take 500 samples μ Place L in a 1.5mL EP tube and freeze at -80 ℃ for later use.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-27', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of liver cancer markers AKR1B10, AFP, AFP-L3% and DCP before and after TACE', 'timeFrame': 'baseline, 1 month and 3 months', 'description': 'Liver cancer markers AKR1B10, AFP, AFP-L3 and DCP are measured before TACE, 1 month and 3 months after TACE in order to evaluate the course of these markers after the intervention'}], 'secondaryOutcomes': [{'measure': 'long-term survival (1-year, 3-year, 5-year)', 'timeFrame': 'up to 5 years', 'description': 'Patients with low AKR1B10 levels have a higher survival rate'}, {'measure': 'progression- free - time', 'timeFrame': 'up to 5 years', 'description': 'Patients with low AKR1B10 levels have a longer progression- free - time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKR1B10'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31248666', 'type': 'BACKGROUND', 'citation': 'Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.'}, {'pmid': '30207593', 'type': 'BACKGROUND', 'citation': 'Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.'}, {'pmid': '34414120', 'type': 'BACKGROUND', 'citation': 'Zhu XD, Huang C, Shen YH, Ji Y, Ge NL, Qu XD, Chen L, Shi WK, Li ML, Zhu JJ, Tan CJ, Tang ZY, Zhou J, Fan J, Sun HC. Downstaging and Resection of Initially Unresectable Hepatocellular Carcinoma with Tyrosine Kinase Inhibitor and Anti-PD-1 Antibody Combinations. Liver Cancer. 2021 Jul;10(4):320-329. doi: 10.1159/000514313. Epub 2021 Mar 30.'}, {'pmid': '29420221', 'type': 'BACKGROUND', 'citation': 'Wang Z, Ren Z, Chen Y, Hu J, Yang G, Yu L, Yang X, Huang A, Zhang X, Zhou S, Sun H, Wang Y, Ge N, Xu X, Tang Z, Lau W, Fan J, Wang J, Zhou J. Adjuvant Transarterial Chemoembolization for HBV-Related Hepatocellular Carcinoma After Resection: A Randomized Controlled Study. Clin Cancer Res. 2018 May 1;24(9):2074-2081. doi: 10.1158/1078-0432.CCR-17-2899. Epub 2018 Feb 2.'}, {'pmid': '17133456', 'type': 'RESULT', 'citation': 'Tateishi R, Shiina S, Yoshida H, Teratani T, Obi S, Yamashiki N, Yoshida H, Akamatsu M, Kawabe T, Omata M. Prediction of recurrence of hepatocellular carcinoma after curative ablation using three tumor markers. Hepatology. 2006 Dec;44(6):1518-27. doi: 10.1002/hep.21408.'}, {'pmid': '32056353', 'type': 'RESULT', 'citation': 'Yoo J, Lee MW, Lee DH, Lee JH, Han JK. Evaluation of a serum tumour marker-based recurrence prediction model after radiofrequency ablation for hepatocellular carcinoma. Liver Int. 2020 May;40(5):1189-1200. doi: 10.1111/liv.14406. Epub 2020 Mar 13.'}, {'pmid': '30672601', 'type': 'RESULT', 'citation': 'Ye X, Li C, Zu X, Lin M, Liu Q, Liu J, Xu G, Chen Z, Xu Y, Liu L, Luo D, Cao Z, Shi G, Feng Z, Deng H, Liao Q, Cai C, Liao DF, Wang J, Jin J, Cao D. A Large-Scale Multicenter Study Validates Aldo-Keto Reductase Family 1 Member B10 as a Prevalent Serum Marker for Detection of Hepatocellular Carcinoma. Hepatology. 2019 Jun;69(6):2489-2501. doi: 10.1002/hep.30519. Epub 2019 Apr 6.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov', 'label': 'Pubmed'}]}, 'descriptionModule': {'briefSummary': 'Primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in China, posing a serious threat to the lives and health of the Chinese people . At present, non-surgical treatment methods are often used, such as radiofrequency ablation (RFA), Transcatheter arterial chemoembolization (TACE), radiation therapy, and systemic anti-tumor therapy. However, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include AFP, AFP-L3%, DCP, etc. , but there are no reports on whether AKR1B10 can be used for the efficacy evaluation of these treatment methods.Therefore, this project aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment.', 'detailedDescription': 'Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation (TACE) are enrolled in this clinical trial. In the early stage, a research team detected the levels of AKR1B10 in serum samples from 477 normal individuals, 107 benign liver tumors, 32 patients with chronic hepatitis B, 78 patients with liver cirrhosis, and 482 patients with liver cancer, and evaluated its early diagnostic value in liver cancer. It was found that AKR1B10 protein, as a serum marker for liver cancer, had significantly better performance than AFP, mainly reflected in three aspects: first, it is more sensitive, The normal background level (reference range) of AKR1B10 is significantly lower than AFP, which means that during clinical testing, changes in serum concentration are more pronounced, making it easier to identify asymptomatic early liver cancer patients; Secondly, it is more specific and has a higher detection rate for liver cancer, with lower false positive and false negative rates. In addition, more than 70% of liver cancer patients who test negative for AFP will be tested positive for AKR1B10, resulting in lower rates of missed diagnosis and misdiagnosis; Thirdly, the time to reflect changes in the condition is 6-7 times faster than AFP. The half-life of AKR1B10 is 23 hours, while AFP has a half-life of 6-7 days.This project mainly aims to explore the clinical value of AKR1B10 in evaluating the efficacy of liver cancer treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All participants have signed an informed consent form, agreeing that their samples and related information can be used for all medical studies.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age between 18 and 80\n* diagnosis of HCC according the AASLD criteria\n* TACE is planned\n* resection is impossible\n* No significant underlying medical illness affecting patient's survival\n* Patients available for regular follow-up according to the study protocol\n\nExclusion Criteria:\n\n* Previous history of other tumors;\n* Combined with other tumors;\n* Received external treatment before admission;\n* Patients who have received blood transfusions within one month;\n* The patient was unable to participate in this study for other reasons."}, 'identificationModule': {'nctId': 'NCT06272656', 'briefTitle': 'Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Third Hospital'}, 'officialTitle': 'Evaluation of AKR1B10 as a New Marker for Interventional Therapy of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'AKR-TACE-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCC Patients treated with TACE', 'description': 'HCC patients who have received initial diagnosis and treatment in our hospital and are planning to receive TACE.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuemin Nan', 'role': 'CONTACT', 'email': 'Hb20231221@163.com', 'phone': '+8633188602489'}, {'name': 'Pei Guo', 'role': 'CONTACT', 'email': 'G545632518@163.com', 'phone': '17835683894'}], 'facility': 'HebeiMUTH', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Yuemin Nan', 'role': 'CONTACT', 'email': 'Hb20231221@163.com', 'phone': '17835683894'}, {'name': 'Pei Guo', 'role': 'CONTACT', 'email': 'G545632518@163.com', 'phone': '17835683894'}], 'overallOfficials': [{'name': 'Yuemin Nan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Medical University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Hepatology Department of integrated Chinese and Western Medicine', 'investigatorFullName': 'Yuemin Nan', 'investigatorAffiliation': 'Hebei Medical University Third Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-16', 'type': 'RELEASE'}, {'date': '2025-03-06', 'type': 'RESET'}, {'date': '2025-04-14', 'type': 'RELEASE'}, {'date': '2025-04-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yuemin Nan, Director of Hepatology Department of integrated Chinese and Western Medicine, Hebei Medical University Third Hospital'}}}}