Early Recurrence After Surgery for Pancreatic Cancer (POCEMON BLUE)

Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma

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:

• How often does early recurrence (within 12 months after surgery) occur?
• When does it happen, and at which anatomical sites (liver, lung, local, peritoneum)?
• How is recurrence detected (imaging or tumor markers)?

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC); Recurrent Pancreatic Adenocarcinoma
• Intervention / Treatment: Procedure: Curative-intent resection (R0, R1)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Italy
  • PD
    • Padua, PD, Italy, 35128
      • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Age ≥18 years
• Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
• Undergoing curative-intent resection (R0 or R1)
• No evidence of distant metastasis at the time of surgery
• Availability of preoperative CA19-9 value and pancreas-protocol CT or MRI
• Ability to provide written informed consent

Exclusion Criteria:

• Withdrawal of informed consent
• Pathological diagnosis other than PDAC (e.g., neuroendocrine tumor, acinar cell carcinoma, invasive IPMN)
• Surgery performed for palliative or diagnostic purposes only
• Intraoperative discovery of unresectable disease or distant metastases
• Gross residual disease (R2 resection)
• Incomplete clinical or radiologic follow-up precluding recurrence assessment
• Absence of adequate preoperative contrast-enhanced pancreas-protocol CT or MRI preventing accurate staging and metastatic evaluation
• Interval >9 months between two consecutive follow-up visits
• Major protocol deviations or insufficient data, as judged by the site investigator

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Padova
• Investigators: Study Chair: Giovanni Marchegiani, MD PhD, University of Padova; Study Director: Giampaolo Perri, MD PhD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pancreatic ductal adenocarcinoma; early recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: AOP3909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No