An observational study in Pancreatic Ductal Adenocarcinoma (PDAC) and Recurrent Pancreatic Adenocarcinoma, sponsored by Azienda Ospedaliera di Padova. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Azienda Ospedaliera di Padova · Observational
The goal of this observational study is to learn about early recurrence after curative-intent surgery for pancreatic cancer. The main questions it aims to answer are:
Adults with histologically confirmed pancreatic ductal adenocarcinoma who undergo curative-intent resection without distant metastases will be enrolled. Participants will be followed according to routine clinical care at each hospital, typically with imaging and CA19-9 blood tests. No study-specific interventions are required.
This international, prospective, multicenter observational study aims to characterize early recurrence (ER) after curative-intent resection of pancreatic ductal adenocarcinoma (PDAC). ER is defined as recurrence occurring within 12 months following surgery.
The study will assess the incidence, timing, anatomical sites, and detection mode (radiologic vs. biochemical) of ER, as well as post-recurrence treatment patterns and short-term outcomes. Secondary aims include comparison between neoadjuvant and upfront surgery cohorts, evaluation of biochemical-only recurrence, and identification of clinical or pathological factors predictive of ER.
Consecutive eligible patients will be enrolled from high-volume pancreatic surgery centers worldwide and followed according to institutional standards of care, typically involving routine imaging and CA19-9 surveillance. Standardized data will be prospectively collected to describe recurrence patterns and post-recurrence management. No study-specific interventions are required.
Azienda Ospedaliera di Padova is the lead sponsor of 38 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (≥18 years) with histologically confirmed pancreatic ductal adenocarcinoma undergoing curative-intent resection (R0 or R1) without evidence of distant metastases at the time of surgery. Both patients treated with neoadjuvant therapy and those undergoing upfront surgery are eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with histologically confirmed PDAC who undergo curative-intent resection (R0 or R1), with no distant metastases, including both upfront and post-neoadjuvant cases.
Procedure: Curative-intent resection (R0, R1)
Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.
Incidence, timing, mode of detection, and anatomical site of early recurrence
Early recurrence (ER) is defined as disease recurrence occurring within 12 months after curative-intent resection (R0 or R1) for pancreatic ductal adenocarcinoma. The incidence, time from surgery to recurrence, mode of detection (radiologic vs biochemical), and anatomical site (liver, lung, local, peritoneum, multiple) will be prospectively assessed.
Time frame: Within 12 months post-surgery
Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery
ER incidence, timing, detection mode, and anatomical sites will be compared between patients who received neoadjuvant therapy and those who underwent upfront surgery.
Time frame: 12 months post-surgery
Incidence and clinical impact of biochemical-only recurrence
Defined as sustained elevation of CA19-9 without radiologic evidence of disease. Clinical outcomes and management strategies in these patients will be analyzed.
Time frame: 12 months post-surgery
Post-recurrence treatment strategies and short-term survival outcomes
Documentation of treatment intent (curative vs palliative) and treatment modality (e.g., chemotherapy, stereotactic body radiotherapy, surgery), with survival outcomes stratified by recurrence type and treatment approach.
Time frame: From recurrence up to 24 months post-surgery
Clinical and pathological predictors of early recurrence
Analysis of demographic, clinical, treatment-related, and pathological factors associated with ER to identify predictors for risk stratification and future surveillance planning.
Time frame: Up to 12 months post-surgery
Validation of futility criteria for upfront surgery patients
Validation of the MetroPancreas model, with futility defined as death or recurrence within 6 months after surgery.
Time frame: Within 6 months post-surgery
Plan to share: No
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Azienda Ospedaliera di Padova