NCT07344116

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
179mo left

Started Jan 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jan 2026Dec 2040

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

11 years

First QC Date

January 7, 2026

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful Establishment of a Hepatobiliary and Pancreatic Tumor Biobank

    up to 5 years

Study Arms (1)

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

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.

Hepatobiliary and Pancreatic Biobank Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CholangiocarcinomaPancreatic Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2040

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share