Pancreatic CancerNCT07827911
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
An observational study of Pancreatic Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
The goal of this observational study is to develop and validate a preoperative immunological signature for predicting postoperative pancreatic fistula (POPF) in adult patients undergoing pancreatic surgery for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- blood sampling
- How many people
- 310 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2027to 4 Jan 2032
- 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 (≥18 years) undergoing elective curative-intent pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy) for benign or malignant pancreatic tumors, with or without neoadjuvant therapy.
Who may be able to join
- Age ≥ 18 years
- Written informed consent provided prior to study participation.
- Patient scheduled to undergo curative-intent pancreatic surgery, with or without neoadjuvant treatment; preoperative biopsy is not required.
- Affiliated with, or beneficiary of, a national health insurance scheme
- Non inclusion Criteria:
- Patients scheduled to undergo total pancreatectomy for oncologic indications (e.g., intraductal papillary mucinous neoplasm [IPMN]). However, if a total pancreatectomy is decided intraoperatively because of a high risk of postoperative pancreatic fistula (POPF), preoperative study data and biological samples will remain eligible for inclusion in analyses comparing immunological signatures, in accordance with current clinical practice
- Individuals in emergency situations, adults under legal protection (guardianship, curatorship, or judicial protection measures), or individuals unable to provide informed consent.
- Inability to comply with study follow-up procedures for geographic, social, or psychological reasons.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Institut Paoli-Calmettes
Marseille, 13009
Jihane PAKRADOUNI, PhD, +334 91223778, drci.up@ipc.unicancer.fr
About this study
The goal of this observational study is to develop and validate a preoperative immunological signature for predicting postoperative pancreatic fistula (POPF) in adult patients undergoing pancreatic surgery for pancreatic cancer.
The main questions it aims to answer are:
Read more
- Can a preoperative immunological signature accurately predict the occurrence of postoperative pancreatic fistula after pancreatic surgery?
- Does the immunological signature provide better predictive performance than currently available predictors? Researchers will also evaluate whether the immunological signature is associated with postoperative readmission, 90-day mortality, and early disease recurrence within one year after surgery.
Participants will:
- Provide a blood sample during the preoperative assessment visit.
- Provide a second blood sample on the day following pancreatic surgery.
- Undergo standard postoperative and oncological follow-up for up to 12 months. This is a prospective, multi-center, open-label observational study conducted at Institut Paoli-Calmettes. A total of 310 participants will be enrolled.
- Conditions
- Pancreatic Cancer
- Being tested
- blood sampling
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Peripheral blood samples will be collected preoperatively (within 21 days before planned pancreatic surgery) and on postoperative day 1. Clinical data will be collected at the same time points and during routine follow-up at 3, 6, and 12 months. Blood samples will be used to characterize an immunological signature and perioperative immune response in patients undergoing pancreatic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing pancreatic surgery | Adult (≥18 years) undergoing elective pancreatic surgery, for a benign or malignant pancreatic tumor. Participants will provide blood samples before surgery and on the first postoperative day for immunological and proteomic analyses aimed at developing and validating a predictive signature of postoperative pancreatic fistula (POPF). Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
Measured: 90 days after pancreatic surgery
Secondary outcomes (5)
90-day Mortality
Measured: 90 days
Change in PreCyte Score Between Preoperative and Postoperative Assessments
Measured: From preoperative assessment (within 21 days before surgery) to postoperative day 1
Predictive Performance of the Immune Signature for 90-Day Readmission and Mortality
Measured: 90days after surgery
One-Year Recurrence-Free Survival and Correlation With Immune Signature
Measured: 1 year after surgery
Comparison of Postoperative PreCyte Score, Drain Fluid Amylase, and C-Reactive Protein for Outcome Prediction
Measured: Postoperative period up to 90 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start4 Jan 2027 (estimated)
- Primary completion4 Jan 2032 (estimated)
- Study completion4 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827911
- Sponsor's protocol ID
- IMMUNOPANC-2-IPC 2024-036
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
- ClinicalTrials.gov ID
- NCT07827911
- Acronym / sponsor ID
- IMMUNOPANC-2-IPC 2024-036
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 4 Jan 2032 (estimated)
- Study completion
- 4 Jan 2032 (estimated)
- First posted
- 18 Sep 2026 (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 develop and validate a preoperative immunological signature for predicting postoperative pancreatic fistula (POPF) in adult patients undergoing pancreatic surgery for pancreatic cancer.
The main questions it aims to answer are:
- Can a preoperative immunological signature accurately predict the occurrence of postoperative pancreatic fistula after pancreatic surgery?
- Does the immunological signature provide better predictive performance than currently available predictors? Researchers will also evaluate whether the immunological signature is associated with postoperative readmission, 90-day mortality, and early disease recurrence within one year after surgery.
Participants will:
- Provide a blood sample during the preoperative assessment visit.
- Provide a second blood sample on the day following pancreatic surgery.
- Undergo standard postoperative and oncological follow-up for up to 12 months. This is a prospective, multi-center, open-label observational study conducted at Institut Paoli-Calmettes. A total of 310 participants will be enrolled.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing pancreatic surgery | – | Other: blood samplingAdult (≥18 years) undergoing elective pancreatic surgery, for a benign or malignant pancreatic tumor. Participants will provide blood samples before surgery and on the first postoperative day for immunological and proteomic analyses aimed at developing and validating a predictive signature of postoperative pancreatic fistula (POPF). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (≥18 years) undergoing elective curative-intent pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy) for benign or malignant pancreatic tumors, with or without neoadjuvant therapy.
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Written informed consent provided prior to study participation.
- Patient scheduled to undergo curative-intent pancreatic surgery, with or without neoadjuvant treatment; preoperative biopsy is not required.
- Affiliated with, or beneficiary of, a national health insurance scheme
- Patients scheduled to undergo total pancreatectomy for oncologic indications (e.g., intraductal papillary mucinous neoplasm [IPMN]). However, if a total pancreatectomy is decided intraoperatively because of a high risk of postoperative pancreatic fistula (POPF), preoperative study data and biological samples will remain eligible for inclusion in analyses comparing immunological signatures, in accordance with current clinical practice
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| blood samplingPeripheral blood samples will be collected preoperatively (within 21 days before planned pancreatic surgery) and on postoperative day 1. Clinical data will be collected at the same time points and during routine follow-up at 3, 6, and 12 months. Blood samples will be used to characterize an immunological signature and perioperative immune response in patients undergoing pancreatic surgery. | Other | Patients undergoing pancreatic surgery |
Primary outcome
Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
Time frame: 90 days after pancreatic surgery
5 secondary outcomes
90-day Mortality
Time frame: 90 days
Change in PreCyte Score Between Preoperative and Postoperative Assessments
Time frame: From preoperative assessment (within 21 days before surgery) to postoperative day 1
Predictive Performance of the Immune Signature for 90-Day Readmission and Mortality
Time frame: 90days after surgery
One-Year Recurrence-Free Survival and Correlation With Immune Signature
Time frame: 1 year after surgery
Comparison of Postoperative PreCyte Score, Drain Fluid Amylase, and C-Reactive Protein for Outcome Prediction
Time frame: Postoperative period up to 90 days after 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 18 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
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 Cancer, run by Institut Paoli-Calmettes at 1 site in France.
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 8 inclusion and 0 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 France. 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?
Contact Jihane PAKRADOUNI, PhD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF) (time frame: 90 days after pancreatic 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 18 Sep 2026.