Early Recurrence After Surgery for Pancreatic Cancer

NCT07241676 | Enrolling By Invitation

• 1 other identifier: AOP3909
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC); Recurrent Pancreatic Adenocarcinoma

Keywords

pancreatic ductal adenocarcinoma; early recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  12 months post-surgery

• Incidence and clinical impact of biochemical-only recurrence

  12 months post-surgery

• Post-recurrence treatment strategies and short-term survival outcomes

  From recurrence up to 24 months post-surgery

• Clinical and pathological predictors of early recurrence

  Up to 12 months post-surgery

• Validation of futility criteria for upfront surgery patients

  Within 6 months post-surgery

Study Arms (1)

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)

Interventions

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.

Curative-intent resection cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

University of Padova

Padua, PD, 35128, Italy

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Marchegiani, MD PhD

  University of Padova

  STUDY CHAIR

• Giampaolo Perri, MD PhD

  University of Padova

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 23, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)