Hepatobiliary and Pancreatic Tumor Biobank

January 7, 2026 updated by: jinyun, Second Affiliated Hospital, School of Medicine, Zhejiang University

Establishment of a Hepatobiliary and Pancreatic Tumor Biobank at a Single Academic Medical Center

This study aims to establish a hepatobiliary and pancreatic tumor biobank at the Second Affiliated Hospital of Zhejiang University School of Medicine. The biobank will systematically collect and store human biological samples, such as blood, tissue, bile, and other body fluids, together with relevant clinical and follow-up information from patients with hepatobiliary and pancreatic tumors, benign hepatobiliary and pancreatic diseases, and selected healthy volunteers.

The collection of samples will be performed without changing routine medical care and will not involve any experimental treatment or additional invasive procedures for research purposes. Biological samples will be obtained during standard clinical diagnosis and treatment, or from remaining specimens after routine clinical use.

All samples and data will be coded and stored according to ethical and legal requirements to protect participants' privacy. The biobank is intended to serve as a long-term research resource to support future basic, translational, and clinical research on hepatobiliary and pancreatic diseases, with the goal of improving understanding of disease mechanisms and advancing medical research in this field.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients receiving care at the Second Affiliated Hospital of Zhejiang University School of Medicine who are diagnosed with hepatobiliary or pancreatic malignant tumors, as well as patients with benign hepatobiliary or pancreatic diseases. Selected healthy adult volunteers may also be included as controls. Participants are enrolled without altering routine medical care, and biological specimens and related clinical data are collected for biobanking and future research purposes.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatobiliary and Pancreatic Biobank Participants
Participants enrolled in this observational biobank study, including patients with hepatobiliary and pancreatic malignant tumors, patients with benign hepatobiliary and pancreatic diseases, and selected healthy volunteers. Biological specimens and related clinical data are collected during routine clinical care without experimental interventions.
Other: No Interventions
This is an observational biobank study. No experimental intervention, treatment, or procedure is assigned as part of the study. Biological specimens are collected only during routine clinical care or from remaining clinical specimens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful Establishment of a Hepatobiliary and Pancreatic Tumor Biobank
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2-HBP-BIOBANK-LJT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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