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Enrolling by Invitation

NCT Number: NCT07241676

Early Recurrence After Surgery for Pancreatic Cancer

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.

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Key information

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC) Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Recurrent Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Padova

Padova, PD, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence, timing, mode of detection, and anatomical site of early recurrence

    Time frame: Within 12 months post-surgery

    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.

Secondary outcomes

  1. Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery

    Time frame: 12 months post-surgery

    ER incidence, timing, detection mode, and anatomical sites will be compared between patients who received neoadjuvant therapy and those who underwent upfront surgery.

  2. Incidence and clinical impact of biochemical-only recurrence

    Time frame: 12 months post-surgery

    Defined as sustained elevation of CA19-9 without radiologic evidence of disease. Clinical outcomes and management strategies in these patients will be analyzed.

  3. Post-recurrence treatment strategies and short-term survival outcomes

    Time frame: From recurrence up to 24 months post-surgery

    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.

  4. Clinical and pathological predictors of early recurrence

    Time frame: Up to 12 months post-surgery

    Analysis of demographic, clinical, treatment-related, and pathological factors associated with ER to identify predictors for risk stratification and future surveillance planning.

  5. Validation of futility criteria for upfront surgery patients

    Time frame: Within 6 months post-surgery

    Validation of the MetroPancreas model, with futility defined as death or recurrence within 6 months after surgery.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

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

Acronym: POCEMON BLUE

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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