Hepatobiliary and Pancreatic Tumor Biobank

This study is designed as a single-center, observational biobank project conducted at the Second Affiliated Hospital of Zhejiang University School of Medicine. The primary purpose of this study is to establish and maintain a structured hepatobiliary and pancreatic tumor biobank that integrates biological specimens with corresponding clinical and follow-up data for long-term research use.

Eligible participants include adult patients diagnosed with hepatobiliary and pancreatic malignant tumors, patients with benign hepatobiliary and pancreatic diseases, and selected healthy volunteers. Enrollment is based on predefined inclusion and exclusion criteria, and participation requires written informed consent unless otherwise approved by the institutional ethics committee for retrospective samples.

Biological specimens collected in this biobank may include peripheral blood, tumor and adjacent non-tumor tissue, bile, and other body fluids. Sample collection is performed without altering routine medical care and does not involve experimental treatments or additional invasive procedures for research purposes. Specimens are obtained during standard diagnostic or therapeutic procedures or from remaining clinical specimens after routine use.

Clinical information associated with each participant, such as demographic characteristics, diagnosis, pathology findings, treatment details, and follow-up outcomes, is systematically collected from existing medical records and follow-up systems. All data and specimens are coded and de-identified prior to storage to ensure participant confidentiality.

The biobank is intended to function as a long-term research infrastructure. Biological samples and data may be used in future ethically approved basic, translational, or clinical studies related to hepatobiliary and pancreatic diseases. Each secondary use of samples or data will require appropriate ethical review and approval in accordance with institutional and regulatory requirements.

Inclusion criteria

• Adults aged 18 years or older.
• Patients diagnosed with hepatobiliary or pancreatic malignant tumors, including but not limited to hepatocellular carcinoma, cholangiocarcinoma, gallbladder cancer, and pancreatic cancer; or patients with benign hepatobiliary or pancreatic diseases; or selected healthy volunteers.
• Receiving medical care or health evaluation at the Second Affiliated Hospital of Zhejiang University School of Medicine.
• Able and willing to provide written informed consent, unless waived or exempted by the institutional ethics committee for retrospective samples.
• Willing to allow collection and storage of biological specimens and related clinical data for research purposes.

Exclusion criteria

• Age younger than 18 years.
• Unable to provide informed consent and without a legally authorized representative.
• Presence of conditions that, in the opinion of the investigators, make participation inappropriate or infeasible.
• Refusal to allow the collection or use of biological specimens or clinical data for research.