Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05759858
Status:
RECRUITING
Last Update Posted:
2023-03-08
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples were restored at -80℃ for 5 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-26', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-02-26', 'lastUpdatePostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Key gene differences in hepatocellular carcinoma', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Key gene differences in hepatocellular carcinoma explored by RNA-seq.'}, {'measure': 'Overall survival', 'timeFrame': 'Through study completion, up to 5 years.', 'description': 'The time from the beginning of treatment to death (for any reason).'}, {'measure': 'Disease-free survival', 'timeFrame': 'Through study completion, up to 5 years.', 'description': 'The time from the beginning of treatment to death (for any reason).'}], 'secondaryOutcomes': [{'measure': 'The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.', 'timeFrame': 'Through study completion, up to 5 years.', 'description': 'The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Genomes', 'Prognosis', 'Gene targeted therapy'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'To explore the key genes of human and mouse hepatocellular carcinoma, identify the key genes and prognostic markers, and develop small molecule drugs targeting the key genes to treat hepatocellular carcinoma.', 'detailedDescription': 'Hepatocellular carcinoma (HCC) is one of the most common solid malignant tumors and the main cause of cancer-related deaths worldwide. About 750000 new cases of liver cancer are diagnosed every year, half of which are in China. The onset of liver cancer is relatively hidden, and there are generally no symptoms in the early stage. When the patient has obvious clinical symptoms, the disease often belongs to the middle and late stages. The first symptom of liver cancer is liver pain, followed by upper abdominal mass. Some patients also showed some complications of liver cirrhosis, such as black stool, hematemesis, jaundice, liver coma, ascites, etc. A few patients were hospitalized due to symptoms caused by metastatic lesions.\n\nAt present, the accuracy of detecting HCC is poor, and the common indicators such as AFP have a certain time lag, which cannot detect patients with liver cancer early. thus, there is an urgent need for a new biomarker for the diagnosis and prognosis of liver cancer. Our research focuses on exploring the key genes of human and mouse hepatocellular carcinoma, identifying the key genes and prognostic markers by means of transcriptome sequencing, and developing small molecule drugs targeting the key genes.\n\nHigh-throughput sequencing technology was used for sequencing analysis to reflect the expression level of mRNA, small RNA, noncoding RNA, or some other markers. After finding the gene difference between the liver cancer sample and the para-cancer sample, relevant immunohistochemical staining was performed to analyze the overall survival time difference between the patients with high-expression genomes and the patients with low-expression genomes. Follow-up cell and animal experiments were carried out to further verify the effect of target genes on the occurrence and development of liver cancer. In the first month after the operation, the patient was followed up at the outpatient clinic to understand the general situation of the patient after the operation, such as diet and appetite, symptom control, such as fever, abdominal pain, and drainage tube removal. One year and three years after the operation, our center will follow up on the patients and re-hospitalization if necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffered hepatocellular carcinoma which was confirmed by pathology. Only surgical treatment is applied to patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Hepatocellular carcinoma confirmed by pathology;\n2. The patient has no combined organic diseases of heart, lung, and kidney, etc;\n3. No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors;\n4. The patient has successfully completed the operation and has complete clinical information and pathological data.\n\nExclusion Criteria:\n\n1. Patients who have previous history of other tumors or have undergone upper abdominal surgery;\n2. Patients with multiple lesions and distant metastasis;\n3. Patients who are complicated with organic diseases of important organs such as heart, lung and kidney and cannot tolerate surgery；\n4. Patients who are more than 75 years old or less than 18 years old.'}, 'identificationModule': {'nctId': 'NCT05759858', 'briefTitle': 'Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Single-center Study of the Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2022-0856'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with hepatocellular carcinoma confirmed by pathology.', 'description': 'Patients with hepatocellular carcinoma confirmed by pathology.', 'interventionNames': ['Other: None of intervention']}], 'interventions': [{'name': 'None of intervention', 'type': 'OTHER', 'description': 'None of the interventions was applied.', 'armGroupLabels': ['Patients with hepatocellular carcinoma confirmed by pathology.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Tian, Doctor', 'role': 'CONTACT', 'phone': '15088673780'}, {'name': 'Yuancong Jiang, Doctor', 'role': 'CONTACT', 'email': 'jiangyuancong@zju.edu.cn', 'phone': '18868107327'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Sheng Yan, Doctor', 'role': 'CONTACT', 'email': 'shengyan@zju.edu.cn', 'phone': '13957161680'}, {'name': 'Yang Tian, Doctor', 'role': 'CONTACT', 'phone': '15088673780'}], 'overallOfficials': [{'name': 'Sheng Yan, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}, {'name': 'Yang Tian, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}, {'name': 'Yuancong Jiang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available from the author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}