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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curative-intent resection cohort | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curative-intent resection (R0, R1) | Procedure | Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-surgery |
| Incidence and clinical impact of biochemical-only recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Marchegiani, MD PhD | University of Padova | Study Chair |
| Giampaolo Perri, MD PhD | University of Padova | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Padova | Padova | PD | 35128 | Italy |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Defined as sustained elevation of CA19-9 without radiologic evidence of disease. Clinical outcomes and management strategies in these patients will be analyzed. |
| 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. | 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. | 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. | Within 6 months post-surgery |