Clinical trial NCT06544083: Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood
Official title: Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Diagnosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female, aged 18 years or older, less than 75 years of age and people who voluntarily sign informed consent

Brief 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.

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 300 subjects, including 100 subjects with liver cancer, 100 subjects with benign diseases, and 100 healthy subjects. The study is divided into two phases, and the first phase of the study will enroll 150 subjects, including 50 subjects with liver cancer, 50 subjects with benign disease, and 50 healthy subjects. The second phase of the study will enroll 150 subjects, including 50 cancer subjects, 50 benign disease subjects, and 50 healthy subjects.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign informed consent.
2. Male or female, age equal to or greater than 18 years and less than 75 years.
3. Patients with liver cancer who have been diagnosed or suspected for the first time within 42 days prior to blood collection
4. 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.
5. Patients with histologically or cytological, radiographically confirmed hepatocellular carcinoma.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Previous organ transplantation or non-autologous bone marrow or stem cell transplantation.
3. 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.
4. History of previous malignant tumors.
5. Having other malignant tumors or multiple primary tumors at the same time.

Primary outcomes:
measure: Peripheral blood protein concentrations
timeFrame: up to 2 years
measure: An early diagnosis model of liver cancer
timeFrame: up to 2 years
Secondary outcomes:
measure: Presence or absence of intrahepatic and extrahepatic metastases of liver cancer
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Weilin Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Yuan Ding
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Zhongquan Sun
role: PRINCIPAL_INVESTIGATOR
References: