Hepotacellular CarcinomaNCT07344116
Hepatobiliary and Pancreatic Tumor Biobank
An observational study of Hepotacellular Carcinoma and Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepotacellular Carcinoma, Cholangiocarcinoma, Pancreatic Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2040
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- No Interventions
- Medical subject headings
- Cholangiocarcinoma, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Establishment of a Hepatobiliary and Pancreatic Tumor Biobank
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepotacellular 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jinyun, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344116
- Sponsor's protocol ID
- ZJU2-HBP-BIOBANK-LJT
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Hepatobiliary and Pancreatic Tumor Biobank at a Single Academic Medical Center
- ClinicalTrials.gov ID
- NCT07344116
- Acronym / sponsor ID
- ZJU2-HBP-BIOBANK-LJT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 15 Jan 2026 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatobiliary and Pancreatic Biobank Participants | – | Other: No InterventionsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| No InterventionsThis 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. | Other | Hepatobiliary and Pancreatic Biobank Participants |
Primary outcome
Successful Establishment of a Hepatobiliary and Pancreatic Tumor Biobank
Time frame: up to 5 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 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepotacellular Carcinoma and Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Establishment of a Hepatobiliary and Pancreatic Tumor Biobank (time frame: up to 5 years). 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 15 Jan 2026.