Hepatocellular CarcinomaNCT05759858
Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- None of intervention
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2022to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffered hepatocellular carcinoma which was confirmed by pathology. Only surgical treatment is applied to patients.
Who may be able to join
- Hepatocellular carcinoma confirmed by pathology;
- The patient has no combined organic diseases of heart, lung, and kidney, etc;
- No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors;
- The patient has successfully completed the operation and has complete clinical information and pathological data.
Who cannot join
- Patients who have previous history of other tumors or have undergone upper abdominal surgery;
- Patients with multiple lesions and distant metastasis;
- Patients who are complicated with organic diseases of important organs such as heart, lung and kidney and cannot tolerate surgery；
- Patients who are more than 75 years old or less than 18 years old.
Trial locations and contacts
1 site in 1 country.
Yang Tian, Doctor contact
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Yang Tian, Doctor, 15088673780
Yuancong Jiang, Doctor, 18868107327, jiangyuancong@zju.edu.cn
About this study
Official title: A Single-center Study of the Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma
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.
Read the detailed description
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.
At 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.
High-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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- None of intervention
- Keywords
- Hepatocellular carcinoma, Genomes, Prognosis, Gene targeted therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None of interventionOther
None of the interventions was applied.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hepatocellular carcinoma confirmed by pathology. | Patients with hepatocellular carcinoma confirmed by pathology. Receives: Other: None of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Key gene differences in hepatocellular carcinoma
Key gene differences in hepatocellular carcinoma explored by RNA-seq.
Measured: Through study completion, an average of 1 year.
Overall survival
The time from the beginning of treatment to death (for any reason).
Measured: Through study completion, up to 5 years.
Disease-free survival
The time from the beginning of treatment to death (for any reason).
Measured: Through study completion, up to 5 years.
Secondary outcomes (1)
The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.
The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.
Measured: Through study completion, up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start14 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng Yan, Doctor, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaYang Tian, Doctor, Study director, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaYuancong Jiang, Doctor, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759858
- Sponsor's protocol ID
- 2022-0856
- Status last verified
- Dec 2022
- First submitted
- 26 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available from the author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study of the Identification and Prognostic Value of Key Genes in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05759858
- Acronym / sponsor ID
- 2022-0856
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Genomes, Prognosis, Gene targeted therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
At 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.
High-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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hepatocellular carcinoma confirmed by pathology. | – | Other: None of interventionPatients with hepatocellular carcinoma confirmed by pathology. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffered hepatocellular carcinoma which was confirmed by pathology. Only surgical treatment is applied to patients.
Key inclusion criteria (4 listed)
- Hepatocellular carcinoma confirmed by pathology;
- The patient has no combined organic diseases of heart, lung, and kidney, etc;
- No history of chemotherapy, radiotherapy, upper abdominal surgery, or combined with other tumors;
- The patient has successfully completed the operation and has complete clinical information and pathological data.
Key exclusion criteria (4 listed)
- Patients who have previous history of other tumors or have undergone upper abdominal surgery;
- Patients with multiple lesions and distant metastasis;
- Patients who are complicated with organic diseases of important organs such as heart, lung and kidney and cannot tolerate surgery；
- Patients who are more than 75 years old or less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None of interventionNone of the interventions was applied. | Other | Patients with hepatocellular carcinoma confirmed by pathology. |
Primary outcome
Key gene differences in hepatocellular carcinoma
Time frame: Through study completion, an average of 1 year.
Key gene differences in hepatocellular carcinoma explored by RNA-seq.
Overall survival
Time frame: Through study completion, up to 5 years.
The time from the beginning of treatment to death (for any reason).
Disease-free survival
Time frame: Through study completion, up to 5 years.
The time from the beginning of treatment to death (for any reason).
1 secondary outcome
The incidence and mortality of postoperative hemorrhage, bile leakage and other complications.
Time frame: Through study completion, up to 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided. Data will be made available from the author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Tian, Doctor contact
Sheng Yan, Doctor study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Yang Tian, Doctor study director
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Yuancong Jiang, Doctor principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Yan, Doctor (13957161680, shengyan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Key gene differences in hepatocellular carcinoma (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.