Liver Metastasis in Pancreatic Ductal Adenocarcinoma: Regulatory Mechanisms and Clinical Significance (PDAC)
Potential Regulatory Mechanisms Underlying the Progression of Pancreatic Ductal Adenocarcinoma and Clinical Significance: A Multicenter Exploratory Study
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.
Studienübersicht
Status
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Yewei Zhang
- Telefonnummer: +86 13813885788
- E-Mail: zhangyewei@njmu.edu.cn
Studienorte
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Jiangsu
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Nanjing, Jiangsu, China
- Rekrutierung
- The Second Affiliated Hospital of Nanjing Medical University
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Kontakt:
- Yewei Zhang
- Telefonnummer: +86 13813885788
- E-Mail: zhangyewei@njmu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
The study population consists of patients with PDAC.Inclusion Criteria:
Aged 18-80 years, regardless of sex; Diagnosis of pancreatic ductal adenocarcinoma (PDAC) or its variants confirmed by imaging or pathological examination; Voluntary provision of written informed consent (ICF) by the patient or their legally authorized representative; Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary PDAC), imaging examination confirmed Liver Metastases from PDAC.
Exclusion Criteria: Presence of other malignant tumors; Receipt of preoperative systemic antitumor therapy (neoadjuvant therapy); Severe cardiac, pulmonary, hepatic, or renal dysfunction; or active infectious diseases; Pregnancy or breastfeeding; Severe coagulation disorders or contraindications to blood collection, or an unacceptably high risk associ
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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PDAC With Liver Metastasis
This cohort includes patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with liver metastasis confirmed by contrast-enhanced CT or MRI at initial diagnosis or during treatment. Clinical characteristics, laboratory findings, imaging data, pathological features, treatment information, and follow-up outcomes will be collected. Available biospecimens may include primary pancreatic tumor tissue, liver metastatic tissue, corresponding adjacent non-tumor pancreatic tissue, normal liver tissue, and peripheral blood samples. No study-assigned interventions will be administered, and all diagnostic and therapeutic decisions will follow routine clinical practice. |
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Patients With Pancreatic Ductal Adenocarcinoma
This cohort includes patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) who meet the predefined eligibility criteria. The cohort includes patients with synchronous liver metastasis at initial diagnosis and those without liver metastasis at baseline who undergo curative-intent surgical resection and are followed for the development of postoperative liver metastasis. Clinical characteristics, pathological findings, imaging data, treatment information, available biospecimens, and longitudinal follow-up outcomes will be collected. The primary outcome is the occurrence of liver metastasis within 12 months after curative-intent resection among eligible patients without liver metastasis at baseline. No study-assigned interventions will be administered, and all treatment decisions will follow routine clinical practice. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Occurrence of Liver Metastasis Within 1 Year After Curative-Intent Resection of Pancreatic Ductal Adenocarcinoma
Zeitfenster: From the date of curative-intent surgical resection to 12 months postoperatively.
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The proportion of patients with pancreatic ductal adenocarcinoma (PDAC) who develop liver metastasis within 1 year after curative-intent surgical resection. Liver metastasis will be assessed by contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI), with pathological confirmation when available. The occurrence of liver metastasis will be recorded as a binary outcome (yes or no). |
From the date of curative-intent surgical resection to 12 months postoperatively.
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Disease-Free Survival (DFS)
Zeitfenster: Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
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Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study. |
Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Progression-Free Survival (PFS)
Zeitfenster: Monitored and reported at 6 months, 1 year, 2 years, and annually thereafter (3, 4, and 5 years) after study entry.
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Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression. |
Monitored and reported at 6 months, 1 year, 2 years, and annually thereafter (3, 4, and 5 years) after study entry.
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Overall Survival (OS)
Zeitfenster: Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
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Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator. |
Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-KY-385-01
- 62227803 (Andere Zuschuss-/Finanzierungsnummer: the National Natural Science Foundation of China)
- 2026YFE0200100 (Andere Zuschuss-/Finanzierungsnummer: the National Key Research and Development Program of China)
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