Overview
Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive malignancy with a poor prognosis, and liver metastasis is a major contributor to treatment failure and reduced survival. Due to the complex mechanisms underlying tumor progression and metastasis, effective early diagnostic biomarkers and targeted therapeutic strategies remain limited. This study aims to investigate the molecular mechanisms underlying PDAC progression and liver metastasis, identify potential biomarkers for early risk prediction and prognostic assessment, and explore novel therapeutic targets to facilitate precision diagnosis and treatment.
Participants will be required to:
- Provide histopathologically confirmed primary PDAC tissue and liver metastatic tissue, together with the corresponding adjacent non-tumor pancreatic tissue
- Undergo regular follow-up visits for monitoring and data collection.
- Allow access to their medical records for relevant clinical information.
Description
Registry Procedures and Quality Assurance
As part of this multicenter observational cohort study, investigators will implement standardized patient registration procedures and comprehensive quality assurance measures as follows:
- Screening and Recruitment: Eligible patients with pancreatic ductal adenocarcinoma (PDAC) will be identified and recruited through participating hospitals, including pancreatic surgery, oncology, and gastroenterology departments and relevant outpatient clinics and inpatient wards. Patients with synchronous or metachronous liver metastasis, as well as patients without liver metastasis following curative-intent surgical resection, will be included according to the predefined eligibility criteria. Both retrospective clinical data collection and prospective participant recruitment will be conducted in accordance with the approved study protocol. Written informed consent will be obtained from prospective participants or their legally authorized representatives, as applicable.
- Data Collection: Clinical data will be collected retrospectively from existing medical records and prospectively through standardized case report forms (CRFs) and longitudinal follow-up. Collected information will include demographic characteristics, medical history, laboratory findings, imaging findings, pathological characteristics, surgical procedures, treatment regimens, metastatic status, and clinical outcomes, including liver metastasis, disease progression, recurrence, and survival. Data entry and verification will be performed by trained research personnel to ensure accuracy, completeness, and consistency across participating centers.
- Biospecimen Collection and Quality Control: Biospecimens, including histopathologically confirmed primary pancreatic tumor tissue, liver metastatic tissue when available, corresponding adjacent non-tumor pancreatic tissue, normal liver tissue when available, and peripheral blood-derived samples, will be collected and managed according to the approved study protocol. Standardized operating procedures (SOPs) will be implemented for specimen collection, processing, labeling, transportation, storage, and laboratory testing. Regular data audits, specimen quality assessments, and laboratory quality control procedures will be conducted to ensure sample integrity, traceability, and analytical reliability.
- Data Management and Quality Assurance: A standardized data management system and predefined data dictionary will be used across participating centers. Data validation will include completeness assessments, range checks, logical consistency checks, and source data verification where applicable. Regular monitoring and cross-center reviews will be conducted to identify and resolve discrepancies, minimize missing data, and maintain the quality and consistency of clinical and biospecimen-related information.
- Data Security and Confidentiality: Participants' privacy and personal information will be strictly protected. Study data and biospecimens will be assigned unique study identification codes, and directly identifiable personal information will be stored separately with restricted access. Electronic data will be maintained in secure, access-controlled systems. All data collection, storage, processing, and sharing procedures will comply with applicable laws, regulations, institutional policies, and ethical requirements.
- Ethical Review and Informed Consent: The study will be conducted in accordance with the Declaration of Helsinki and applicable ethical and regulatory requirements. The study protocol will be reviewed and approved by the relevant institutional ethics committee(s) before study implementation. Written informed consent will be obtained from prospective participants or their legally authorized representatives, as applicable. Retrospective data collection and any applicable waiver of informed consent will be conducted only with the approval of the relevant ethics committee(s).
Eligibility
Inclusion Criteria:
- Aged 18-80 years, regardless of sex.
- Diagnosis of pancreatic ductal adenocarcinoma (PDAC) or its variants confirmed by imaging and/or pathological examination.
- Meeting at least one of the following criteria:
- Liver metastasis from PDAC confirmed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) at initial diagnosis or during the disease course.
- No evidence of liver metastasis at initial diagnosis, followed by curative-intent surgical resection and planned postoperative surveillance for liver metastasis.
- Availability of sufficient clinical information, including demographic characteristics, medical history, imaging and/or pathological findings, treatment information, liver metastasis status, and follow-up outcomes.
- Availability of a unique study identification code to ensure patient traceability and data linkage.
- For prospective enrollment and biospecimen collection, voluntary provision of written informed consent by the patient or their legally authorized representative, as required by the approved study protocol.
Exclusion Criteria:
- Concomitant diagnosis of other malignant tumors.
- Receipt of preoperative systemic antitumor therapy (neoadjuvant therapy) before curative-intent surgical resection, for patients in the resection subgroup.
- Severe cardiac, pulmonary, hepatic, or renal dysfunction.
- Active infectious diseases.
- Pregnancy or breastfeeding.
- Severe coagulation disorders, contraindications to blood collection, or an unacceptably high risk associated with blood collection as assessed by the investigator.
