Pancreatic CancerVEINOPANNCT06478056
Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma
A study testing pancreatectomy in people with Pancreatic Cancer, run by University Hospital, Rouen at 1 site in France.
Trial summary
This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood, portal venous blood, collected intraoperatively, as well as its detection in peritoneal fluid. 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?
- pancreatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age ≥ 18 years
- Patient with operable pancreatic adenocarcinoma (resectable or boderline with or without neoadjuvant therapy) with histological evidence or indirect diagnostic criteria (CA 19-9 Significant (≥ 200 U/ml), pancreatic hypodense lesion without differential diagnosis)
- Biological criteria: Neutrophils > 1,500 cmm, platelet count > 100,000 cmm, creatinine clearance (Cockroft and Gault equation) > 60 ml/min, hemoglobin > 10 g/dl.
- ECOG performance status 0 or 1
- Patient has read and understood the information letter and signed the non-opposition/consent form.
- For an adult unable to give consent: Representative of the adult who has read and understood the information letter and signed the consent form
Who cannot join
- Other active cancer or haematological malignancy
- Uncontrolled congestive heart failure - untreated angina pectoris; recent myocardial infarction (within the last year) - uncontrolled hypertension (SBP > 160 mm or DBP > 100 mm, despite optimal drug therapy), long QT.
- Uncontrolled major infections, chronic infectious diseases, immunodeficiency syndromes
- Premalignant hematological disorders, e.g. myelodysplastic syndrome
- Severe hepatic impairment
- Patients not registered with social security
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- Pregnant, parturient or breast-feeding woman (a pregnancy test will be carried out unless there is a history of hysterectomy, tubal ligation or menopause)
- Person deprived of liberty by an administrative or judicial decision, or person placed under court protection, sub-guardianship or guardianship.
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or to prevent him/her from giving informed consent.
- Treatment contraindicated for venous sampling
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood, portal venous blood, collected intraoperatively, as well as its detection in peritoneal fluid.
Read the detailed description
Pancreatic adenocarcinoma is the 6th most common cancer in France and is expected to be the 2nd leading cause of cancer mortality in Europe by 2030. Its overall 5-year survival for all stages combined is estimated at 7-8%.
Surgery is the only potentially curative treatment for pancreatic adenocarcinoma (PA), although only 10-20% of patients present with resectable disease. The oncological results of surgery alone are disappointing (median overall survival (OS) of 15-20 months and 5-year OS of 8-15%), due to the high frequency of recurrence. For this reason, surgery must be integrated into a comprehensive treatment sequence, also known as multimodal therapy.
Significant progress has been observed over the past 5 years, with a marked increase in median OS in recent clinical trials, and an intensification of perioperative chemotherapy (CT) protocols.
Liquid biopsy and circulating biomarkers show promise for improving the multidisciplinary approach to treatment of pancreatic adenocarcinoma.
Circulating tumor DNA (ctDNA) is the most extensively studied marker in blood liquid biopsies and can provide insight into the molecular profile and individual characteristics of the tumor. This could pave the way for the identification of new therapeutic targets and markers of tumor response to complement diagnosis and provide improved stratified treatment. Similarly, the measurement of tcDNA in peritoneal fluid could provide a better understanding of individual tumour characteristics and the risk of peritoneal metastasis.
It is important to assess whether portal venous ctDNA is likely to provide distinct information from peripheral venous ctDNA; if the two ctDNAs are highly correlated, then it seems unlikely that one can provide complementary information to the other.
In addition, our work would evaluate the prognostic impact of the detection of circulating tumor DNA in portal venous blood collected intraoperatively, as well as its detection in peritoneal fluid.
- Conditions
- Pancreatic Cancer
- Being tested
- pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatectomyProcedure or surgery
patients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | patients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital Receives: Procedure: pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of ctDNA
the level of ctDNA measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery
Measured: Surgery
Secondary outcomes (2)
level of ctDNA
ctDNA levels measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery
Measured: surgery
peritoneal ctDNA level
ctDNA levels measured in peritoneal fluid during surgery.
Measured: surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start28 May 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
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 University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478056
- Sponsor's protocol ID
- 2021/0385/HP
- Acronym
- VEINOPAN
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2024
- Last updated
- 6 Feb 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Portal and Peripheral Venous ctDNA in Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06478056
- Acronym / sponsor ID
- VEINOPAN / 2021/0385/HP
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 27 Jun 2024 (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.
This study aims to evaluate the prognostic impact of the detection of circulating tumor DNA in peripheral venous blood, portal venous blood, collected intraoperatively, as well as its detection in peritoneal fluid.
Detailed description
Pancreatic adenocarcinoma is the 6th most common cancer in France and is expected to be the 2nd leading cause of cancer mortality in Europe by 2030. Its overall 5-year survival for all stages combined is estimated at 7-8%.
Surgery is the only potentially curative treatment for pancreatic adenocarcinoma (PA), although only 10-20% of patients present with resectable disease. The oncological results of surgery alone are disappointing (median overall survival (OS) of 15-20 months and 5-year OS of 8-15%), due to the high frequency of recurrence. For this reason, surgery must be integrated into a comprehensive treatment sequence, also known as multimodal therapy.
Significant progress has been observed over the past 5 years, with a marked increase in median OS in recent clinical trials, and an intensification of perioperative chemotherapy (CT) protocols.
Liquid biopsy and circulating biomarkers show promise for improving the multidisciplinary approach to treatment of pancreatic adenocarcinoma.
Circulating tumor DNA (ctDNA) is the most extensively studied marker in blood liquid biopsies and can provide insight into the molecular profile and individual characteristics of the tumor. This could pave the way for the identification of new therapeutic targets and markers of tumor response to complement diagnosis and provide improved stratified treatment. Similarly, the measurement of tcDNA in peritoneal fluid could provide a better understanding of individual tumour characteristics and the risk of peritoneal metastasis.
It is important to assess whether portal venous ctDNA is likely to provide distinct information from peripheral venous ctDNA; if the two ctDNAs are highly correlated, then it seems unlikely that one can provide complementary information to the other.
In addition, our work would evaluate the prognostic impact of the detection of circulating tumor DNA in portal venous blood collected intraoperatively, as well as its detection in peritoneal fluid.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: pancreatectomypatients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patient with operable pancreatic adenocarcinoma (resectable or boderline with or without neoadjuvant therapy) with histological evidence or indirect diagnostic criteria (CA 19-9 Significant (≥ 200 U/ml), pancreatic hypodense lesion without differential diagnosis)
- Biological criteria: Neutrophils > 1,500 cmm, platelet count > 100,000 cmm, creatinine clearance (Cockroft and Gault equation) > 60 ml/min, hemoglobin > 10 g/dl.
- ECOG performance status 0 or 1
- Patient has read and understood the information letter and signed the non-opposition/consent form.
Key exclusion criteria (10 listed)
- Other active cancer or haematological malignancy
- Uncontrolled congestive heart failure - untreated angina pectoris; recent myocardial infarction (within the last year) - uncontrolled hypertension (SBP > 160 mm or DBP > 100 mm, despite optimal drug therapy), long QT.
- Uncontrolled major infections, chronic infectious diseases, immunodeficiency syndromes
- Premalignant hematological disorders, e.g. myelodysplastic syndrome
- Severe hepatic impairment
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 |
|---|---|---|
| pancreatectomypatients operated on for pancreatic adenocarcinoma in the digestive surgery department of Rouen University Hospital | Procedure or surgery | Surgery |
Primary outcome
level of ctDNA
Time frame: Surgery
the level of ctDNA measured in peripheral venous and portal blood before and after mobilization of the specimen during surgery
2 secondary outcomes
level of ctDNA
Time frame: surgery
peritoneal ctDNA level
Time frame: surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pancreatectomy in people with Pancreatic Cancer, run by University Hospital, Rouen 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
level of ctDNA (time frame: 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 6 Feb 2026.