Hepatocellular CarcinomaNCT06544083
Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood
An observational study of Hepatocellular Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
By collecting blood samples from liver cancer patients and healthy individuals, and comparing the blood protein profiles of the two, the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Proteomics
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female, aged 18 years or older, less than 75 years of age and people who voluntarily sign informed consent
Who may be able to join
- Voluntarily sign informed consent.
- Male or female, age equal to or greater than 18 years and less than 75 years.
- Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection
- The subject has not undergone any local or systemic anti-tumor therapy before blood collection, including (but not limited to) tumor surgical treatment for any purpose, local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenic drugs), immunotherapy, cancer vaccine and hormone therapy, etc.
- Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.
Who cannot join
- Female subjects who are pregnant or breastfeeding.
- Previous organ transplantation or non-autologous bone marrow or stem cell transplantation.
- Received drugs with anti-tumor effects for other diseases within 30 days before blood collection, such as drugs used for the treatment of immunorheumatic diseases such as methotrexate, cyclophosphamide, thiazoprine, chlorambucil, etc., drugs for the treatment of breast diseases, such as tamoxifen, etc.
- History of previous malignant tumors.
- Having other malignant tumors or multiple primary tumors at the same time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Weilin Wang, +86 13606642087, wam@zju.edu.cn
About this study
Official title: Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Multi-center, Prospective Study
By collecting blood samples from liver cancer patients and healthy individuals, and comparing the blood protein profiles of the two, the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy.
Read the detailed description
This study is a prospective study to establish an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and verify its efficacy.
The study was divided into two phases: model establishment and model validation. In the model establishment stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were prospectively collected, and in the model validation stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were included in multiple centers, and a single-blind setting (analyst blinding) was carried out. The diagnosis, follow-up treatment and follow-up of subjects with cancer and benign lesions follow the routine clinical diagnosis and treatment procedures of the research center, and are not affected by this study. Healthy subjects undergo clinical examination in healthy persons according to the protocol of this study. The follow-up diagnosis, treatment and follow-up of subjects judged to be cancer, suspected cancer, benign lesions, and suspected benign lesions during the clinical examination will follow the routine clinical diagnosis and treatment procedures of the research center, and will not be affected by this study. This study is expected to enroll 600 subjects, including 300 subjects with liver cancer, 150 subjects with benign diseases, and 150 healthy subjects. The study is divided into two phases, and the first phase of the study will enroll 200 subjects at the Second Affiliated Hospital of Zhejiang University School of Medicine, including 100 subjects with liver cancer, 50 subjects with benign disease, and 50 healthy subjects. The second phase of the study will enroll 100 subjects at each center, including 50 cancer subjects, 25 benign disease subjects, and 25 healthy subjects.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Proteomics
- Keywords
- Hepatocellular Carcinoma, Diagnosis
- Medical subject headings
- Carcinoma, Hepatocellular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProteomicsDiagnostic test
Proteomic is performed on all blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma group | Patients with histologically or cytological, imaging confirmed untreated hepatocellular carcinoma. Receives: Diagnostic Test: Proteomics | |
| Benign liver lesions group | Untreated patients with confirmed or suspected benign liver lesions by histopathology, or with high suspicion of benign liver lesions by imaging evaluation or other routine clinical diagnosis Receives: Diagnostic Test: Proteomics | |
| Healthy people group | People without any liver disease Receives: Diagnostic Test: Proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral blood protein concentrations
The blood of liver cancer patients before treatment and the blood of non-liver cancer subjects were collected, and the differences between the peripheral blood protein characteristics of the above groups and those of non-liver cancer subjects and the blood protein characteristics that can be used for tissue traceability were analyzed. Peripheral blood protein concentrations were quantitatively measured by proteomic methods. Univariate COX regression method will be used to analyze whether the differences between the two groups are related to the diagnosis of liver cancer.
Measured: up to 2 years
An early diagnosis model of liver cancer
The sensitivity and specificity of an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and the accuracy of tissue traceability were established and verified.
Measured: up to 2 years
Secondary outcomes (1)
Presence or absence of intrahepatic and extrahepatic metastases of liver cancer
The number and size of intrahepatic and extrahepatic metastases of liver cancer were measured by imaging methods to evaluate whether they were associated with the high risk predicted by the diagnostic model of liver cancer.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start5 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Anhui Provincial Hospital, Beijing Tsinghua Changgeng Hospital, Qilu Hospital of Shandong University, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Third Affiliated Hospital of Xinjiang Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital Xi'an Jiaotong University, Wuhan TongJi Hospital
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaYuan Ding, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaZhongquan Sun, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544083
- Sponsor's protocol ID
- 2024-0167
- Status last verified
- May 2026
- First submitted
- 16 Apr 2024
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Multi-center, Prospective Study
- ClinicalTrials.gov ID
- NCT06544083
- Acronym / sponsor ID
- 2024-0167
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Anhui Provincial Hospital, Beijing Tsinghua Changgeng Hospital, Qilu Hospital of Shandong University, West China Hospital, The First Affiliated Hospital of Zhengzhou University, Third Affiliated Hospital of Xinjiang Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital Xi'an Jiaotong University, Wuhan TongJi Hospital
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
By collecting blood samples from liver cancer patients and healthy individuals, and comparing the blood protein profiles of the two, the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy.
Detailed description
This study is a prospective study to establish an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and verify its efficacy.
The study was divided into two phases: model establishment and model validation. In the model establishment stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were prospectively collected, and in the model validation stage, blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were included in multiple centers, and a single-blind setting (analyst blinding) was carried out. The diagnosis, follow-up treatment and follow-up of subjects with cancer and benign lesions follow the routine clinical diagnosis and treatment procedures of the research center, and are not affected by this study. Healthy subjects undergo clinical examination in healthy persons according to the protocol of this study. The follow-up diagnosis, treatment and follow-up of subjects judged to be cancer, suspected cancer, benign lesions, and suspected benign lesions during the clinical examination will follow the routine clinical diagnosis and treatment procedures of the research center, and will not be affected by this study. This study is expected to enroll 600 subjects, including 300 subjects with liver cancer, 150 subjects with benign diseases, and 150 healthy subjects. The study is divided into two phases, and the first phase of the study will enroll 200 subjects at the Second Affiliated Hospital of Zhejiang University School of Medicine, including 100 subjects with liver cancer, 50 subjects with benign disease, and 50 healthy subjects. The second phase of the study will enroll 100 subjects at each center, including 50 cancer subjects, 25 benign disease subjects, and 25 healthy subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma group | – | Diagnostic Test: ProteomicsPatients with histologically or cytological, imaging confirmed untreated hepatocellular carcinoma. |
| Benign liver lesions group | – | Diagnostic Test: ProteomicsUntreated patients with confirmed or suspected benign liver lesions by histopathology, or with high suspicion of benign liver lesions by imaging evaluation or other routine clinical diagnosis |
| Healthy people group | – | Diagnostic Test: ProteomicsPeople without any liver disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female, aged 18 years or older, less than 75 years of age and people who voluntarily sign informed consent
Key inclusion criteria (5 listed)
- Voluntarily sign informed consent.
- Male or female, age equal to or greater than 18 years and less than 75 years.
- Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection
- The subject has not undergone any local or systemic anti-tumor therapy before blood collection, including (but not limited to) tumor surgical treatment for any purpose, local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenic drugs), immunotherapy, cancer vaccine and hormone therapy, etc.
- Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.
Key exclusion criteria (5 listed)
- Female subjects who are pregnant or breastfeeding.
- Previous organ transplantation or non-autologous bone marrow or stem cell transplantation.
- Received drugs with anti-tumor effects for other diseases within 30 days before blood collection, such as drugs used for the treatment of immunorheumatic diseases such as methotrexate, cyclophosphamide, thiazoprine, chlorambucil, etc., drugs for the treatment of breast diseases, such as tamoxifen, etc.
- History of previous malignant tumors.
- Having other malignant tumors or multiple primary tumors at the same time.
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 |
|---|---|---|
| ProteomicsProteomic is performed on all blood samples. | Diagnostic test | Benign liver lesions group, Healthy people group, Hepatocellular carcinoma group |
Primary outcome
Peripheral blood protein concentrations
Time frame: up to 2 years
The blood of liver cancer patients before treatment and the blood of non-liver cancer subjects were collected, and the differences between the peripheral blood protein characteristics of the above groups and those of non-liver cancer subjects and the blood protein characteristics that can be used for tissue traceability were analyzed. Peripheral blood protein concentrations were quantitatively measured by proteomic methods. Univariate COX regression method will be used to analyze whether the differences between the two groups are related to the diagnosis of liver cancer.
An early diagnosis model of liver cancer
Time frame: up to 2 years
The sensitivity and specificity of an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and the accuracy of tissue traceability were established and verified.
1 secondary outcome
Presence or absence of intrahepatic and extrahepatic metastases of liver cancer
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Weilin Wang principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Yuan Ding principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Zhongquan Sun 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weilin Wang (13606642087, wam@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood protein concentrations (time frame: up to 2 years). The study lists 2 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 27 May 2026.