Pancreatic Ductal Adenocarcinoma (PDAC)POCEMON BLUENCT07241676
Early Recurrence After Surgery for Pancreatic Cancer
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC) and Recurrent Pancreatic Adenocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Recurrent Pancreatic Adenocarcinoma
- What is being tested?
- Curative-intent resection (R0, R1)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 23 Oct 2025to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Curative-intent resection (R0, R1)
- Keywords
- pancreatic ductal adenocarcinoma, early recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative-intent resection (R0, R1)Procedure or surgery
Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Curative-intent resection (R0, R1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months post-surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start23 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Giovanni Marchegiani, MD PhD, Study chair, University of PadovaGiampaolo Perri, MD PhD, Study director, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241676
- Sponsor's protocol ID
- AOP3909
- Acronym
- POCEMON BLUE
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07241676
- Acronym / sponsor ID
- POCEMON BLUE / AOP3909
- Keywords
- pancreatic ductal adenocarcinoma, early recurrence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curative-intent resection cohort | – | Procedure: Curative-intent resection (R0, R1)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Curative-intent resection cohort |
Primary outcome
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.
5 secondary outcomes
Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery
Time frame: 12 months post-surgery
Incidence and clinical impact of biochemical-only recurrence
Time frame: 12 months post-surgery
Post-recurrence treatment strategies and short-term survival outcomes
Time frame: From recurrence up to 24 months post-surgery
Clinical and pathological predictors of early recurrence
Time frame: Up to 12 months post-surgery
Validation of futility criteria for upfront surgery patients
Time frame: Within 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Marchegiani, MD PhD study chair
University of Padova
Giampaolo Perri, MD PhD study director
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (PDAC) and Recurrent Pancreatic Adenocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, timing, mode of detection, and anatomical site of early recurrence (time frame: Within 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.