Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT07147335
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biospecimen Description: blood (2 mL) was collected in a plain VACUTAINER tube containing no anticoagulant and allowed to clot at room temperature for 30 minutes, followed by centrifugation at 1,500g for 10 minutes at 4°C to remove clots. Supernatants (serum) were immediately transferred into clean polypropylene tubes (200 µL per tube) using a Pasteur pipette, encoded with a number, and stored or transported at -80°C. Serum samples that were hemolyzed, icteric, or lipemic were excluded.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCC', 'timeFrame': '36 mouths', 'description': 'In this clinical trial, all patients with cirrhosis underwent ultrasound and serum AKR1B10 tests every three months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKR1B10', 'Hepotacellular carcinoma', 'cirrhosis'], 'conditions': ['Cirrhosis', 'Hepotacellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '38619448', 'type': 'BACKGROUND', 'citation': 'Yeo YH, Lee YT, Tseng HR, Zhu Y, You S, Agopian VG, Yang JD. Alpha-fetoprotein: Past, present, and future. Hepatol Commun. 2024 Apr 12;8(5):e0422. doi: 10.1097/HC9.0000000000000422. eCollection 2024 May 1.'}, {'pmid': '33734139', 'type': 'BACKGROUND', 'citation': 'Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.'}, {'pmid': '26078578', 'type': 'BACKGROUND', 'citation': 'Ilikhan SU, Bilici M, Sahin H, Akca AS, Can M, Oz II, Guven B, Buyukuysal MC, Ustundag Y. Assessment of the correlation between serum prolidase and alpha-fetoprotein levels in patients with hepatocellular carcinoma. World J Gastroenterol. 2015 Jun 14;21(22):6999-7007. doi: 10.3748/wjg.v21.i22.6999.'}, {'pmid': '29395269', 'type': 'BACKGROUND', 'citation': 'Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.'}, {'pmid': '22729709', 'type': 'BACKGROUND', 'citation': 'Kapoor S. AKR1B10 and its emerging role in tumor carcinogenesis and as a cancer biomarker. Int J Cancer. 2013 Jan 15;132(2):495. doi: 10.1002/ijc.27685. Epub 2012 Jul 30. No abstract available.'}, {'pmid': '30672601', 'type': 'BACKGROUND', '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.'}, {'pmid': '33579421', 'type': 'BACKGROUND', 'citation': 'Chidambaranathan-Reghupaty S, Fisher PB, Sarkar D. Hepatocellular carcinoma (HCC): Epidemiology, etiology and molecular classification. Adv Cancer Res. 2021;149:1-61. doi: 10.1016/bs.acr.2020.10.001. Epub 2020 Nov 28.'}, {'pmid': '12901288', 'type': 'BACKGROUND', 'citation': 'Zhu AX. Hepatocellular carcinoma: are we making progress? Cancer Invest. 2003 Jun;21(3):418-28. doi: 10.1081/cnv-120018233.'}]}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC) is a globally prevalent malignancy. In its characteristic "chronic hepatitis-liver cirrhosis-HCC" progression trilogy, patients with cirrhosis demonstrate a 5-year HCC incidence rate of 3%-5%, yet effective monitoring strategies remain lacking. Current early diagnosis relies on the combination of imaging techniques and serum alpha-fetoprotein (AFP), but AFP measurements are frequently confounded by pregnancy and liver diseases, resulting in suboptimal sensitivity and specificity. In recent years, novel tumor biomarkers such as AKR1B10 (Aldo-keto reductase family 1 member B10) have been examined. This multicenter prospective cohort study aims to validate the predictive value of serum AKR1B10 for malignant transformation in cirrhosis-HCC progression, and evaluate its combined efficacy with existing risk prediction models, ultimately establishing a high-sensitivity early diagnostic strategy for clinical implementation.', 'detailedDescription': 'Patients with liver cirrhosis and chronic hepatitis were enrolled in this clinical trial. The study was designed to investigate the clinical value of serum AKR1B10 in hepatocellular carcinoma (HCC) risk prediction, early diagnosis, and screening among individuals with cirrhosis. Previous studies have demonstrated elevated AKR1B10 levels in small tumor nodules measuring \\<2 cm. Based on these findings, Investigators hypothesize that in a subset of cirrhotic patients, hepatic tissues may harbor ultra-early carcinogenic or precancerous lesions undetectable by current clinical modalities, and that serum AKR1B10 could serve as an early warning signal for such occult malignant transformation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Hepatitis and Liver Cirrhosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets diagnostic criteria for liver cirrhosis and chronic hepatitis\n* Aged 18-75 years, regardless of gender\n* Willing to participate in the study and provides signed informed consent\n* Has not participated in other clinical trials within the last 3 months\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Incomplete clinical data, serological or imaging records\n* Lost to follow-up prior to reaching the observational endpoints\n* Aged \\<18 years or \\>75 years\n* Concurrent severe systemic diseases (e.g., involving cardiovascular, cerebral, pulmonary, renal, or hematopoietic systems)\n* Current or recent (within 3 months) participation in other clinical trials\n* Diagnosed with hepatocellular carcinoma (HCC)'}, 'identificationModule': {'nctId': 'NCT07147335', 'acronym': 'AKR1B10', 'briefTitle': 'The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of University of South China'}, 'officialTitle': 'The Role of Serum AKR1B10 in Early Warning of Hepatocellular Carcinoma in Cirrhosis Patients ------ Risk Early Warning and Follow-up Study', 'orgStudyIdInfo': {'id': "AKR1B10's clinical study"}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The serum AKR1B10 concentration was high in patients with cirrhosis.', 'description': 'The serum AKR1B10 concentration was high in patients with cirrhosis.', 'interventionNames': ['Diagnostic Test: serum AKR1B10 levels']}, {'label': 'The serum AKR1B10 concentration was low in patients with cirrhosis', 'description': 'The serum AKR1B10 concentration was low in patients with cirrhosis', 'interventionNames': ['Diagnostic Test: serum AKR1B10 levels']}], 'interventions': [{'name': 'serum AKR1B10 levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Investigators collected blood from the patients every three months to test their serum AKR1B10 levels.', 'armGroupLabels': ['The serum AKR1B10 concentration was high in patients with cirrhosis.', 'The serum AKR1B10 concentration was low in patients with cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '421001', 'city': 'Hengyang', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Zeng, PhD', 'role': 'CONTACT', 'email': 'xzeng@usc.edu.cn', 'phone': '17773486769'}], 'facility': 'University of South China', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}], 'centralContacts': [{'name': 'Xi Zeng, PhD', 'role': 'CONTACT', 'email': 'xzeng@usc.edu.cn', 'phone': '17773486769'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of University of South China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Director', 'investigatorFullName': 'Zhongtian Peng', 'investigatorAffiliation': 'The First Affiliated Hospital of University of South China'}}}}