Resectable Pancreatic CancerICAPACNCT03435536
Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer
A study testing Blood samples in people with Resectable Pancreatic Cancer, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Cancer
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2018to 20 Jun 2022
- 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
- Every patient taken care by Toulouse University Hospital for the resection of a non-metastatic pancreatic adenocarcinoma by whipple resection.
- Patient aged over 18 years old
- Patient having given his written consent
- Patient with social insurance coverage
Who cannot join
- Patients who had surgery, but their pathological examination of the resected specimen does not contain adenocarcinoma.
- Patient for whom the surgery was not realized (exploratory laparotomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.
Read the detailed description
The investigators will analyze if the tumor mobilization increases circulating DNA rate in peripheral and portal blood. Moreover, circulating tumor DNA will be measured during 12 months after surgery in peripheral blood. They will use a gene mutation detection technique called Next Generation Sequencing (NGS) which is more specific than a simple Polymerase Chain Reaction (PCR).
- Conditions
- Resectable Pancreatic Cancer
- Being tested
- Blood samples
- Keywords
- circulating tumor DNA, kinetic, pancreatic cancer, pancreatoduodenectomy, Next Generation Sequencing
- 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 samplesOther
Blood samples will be taken to analyze the circulating tumor DNA rate by NGS
| Study group | Role | What they receive |
|---|---|---|
| Circulating tumor DNA | Experimental | circulating tumor DNA rate at various times of pancreatic cancer resection Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.
To analyse circulating tumor DNA rate in the portal vein and in peripheral blood at various times of pancreatic cancer resection. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, 10days , one month, 3 months, 6 months and one year after surgery)
Measured: Kinetic up to one year
Secondary outcomes (2)
Overall survival
to analyse correlation between circulating tumor DNA rate and overall survival and survival without recurrence. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, one month, 3 months, 6 months and one year after surgery)
Measured: Kinetic up to one year
Correlation between circulating tumor DNA rate and Ca19.9 dosage
to analyse correlation between circulating tumor DNA and Ca19.9 rate after dosage of C19.9. Kinetic to 1 day before surgery, and after surgery (on day, one month, 3 months, 6 months and one year after surgery)
Measured: Kinetic up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start26 Feb 2018
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel CUELLAR, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435536
- Sponsor's protocol ID
- RC31/17/0327
- Acronym
- ICAPAC
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2018
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maulat C, Canivet C, Cabarrou B, Pradines A, Selves J, Casanova A, Doussine A, Hanoun N, Cuellar E, Boulard P, Carrere N, Buscail L, Bournet B, Muscari F, Cordelier P. Prognostic impact of circulating tumor DNA detection in portal and peripheral blood in resected pancreatic ductal adenocarcinoma patients. Sci Rep. 2024 Nov 8;14(1):27296. doi: 10.1038/s41598-024-76903-y.
PubMed 39516243
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pancreatic Adenocarcinoma Excision Surgery on Peripheral and Portal Circulating Tumor DNA: Prospective Exploratory Pilot Study.
- ClinicalTrials.gov ID
- NCT03435536
- Acronym / sponsor ID
- ICAPAC / RC31/17/0327
- Conditions
- Resectable Pancreatic Cancer
- Keywords
- circulating tumor DNA, kinetic, pancreatic cancer, pancreatoduodenectomy, Next Generation Sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 19 Feb 2018 (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.
Pancreatic cancer represents the fourth cause of death by cancer in western countries. The only curative treatment is surgery but this one is possible only in 10 to 15 % of cases. To date, there are few biomarkers in circulating blood as prognostic or diagnostic markers in pancreatic cancer. The purpose of this study is to determine if the pancreatic tumor mobilization during its resection impacts the quantity of circulating tumor DNA in peripheral and portal blood.
Detailed description
The investigators will analyze if the tumor mobilization increases circulating DNA rate in peripheral and portal blood. Moreover, circulating tumor DNA will be measured during 12 months after surgery in peripheral blood. They will use a gene mutation detection technique called Next Generation Sequencing (NGS) which is more specific than a simple Polymerase Chain Reaction (PCR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulating tumor DNA | Experimental | Other: Blood samplescirculating tumor DNA rate at various times of pancreatic cancer resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Every patient taken care by Toulouse University Hospital for the resection of a non-metastatic pancreatic adenocarcinoma by whipple resection.
- Patient aged over 18 years old
- Patient having given his written consent
- Patient with social insurance coverage
Key exclusion criteria (2 listed)
- Patients who had surgery, but their pathological examination of the resected specimen does not contain adenocarcinoma.
- Patient for whom the surgery was not realized (exploratory laparotomy)
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 samplesBlood samples will be taken to analyze the circulating tumor DNA rate by NGS | Other | Circulating tumor DNA |
Primary outcome
Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer.
Time frame: Kinetic up to one year
To analyse circulating tumor DNA rate in the portal vein and in peripheral blood at various times of pancreatic cancer resection. Kinetic to 1 day before surgery, during surgery and after surgery (1 day, 10days , one month, 3 months, 6 months and one year after surgery)
2 secondary outcomes
Overall survival
Time frame: Kinetic up to one year
Correlation between circulating tumor DNA rate and Ca19.9 dosage
Time frame: Kinetic up to one year
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 28 Nov 2025.
- Results publication: PubMed 39516243Maulat C, Canivet C, Cabarrou B, Pradines A, Selves J, Casanova A, Doussine A, Hanoun N, Cuellar E, Boulard P, Carrere N, Buscail L, Bournet B, Muscari F, Cordelier P. Prognostic impact of circulating tumor DNA detection in portal and peripheral blood in resected pancreatic ductal adenocarcinoma patients. Sci Rep. 2024 Nov 8;14(1):27296. doi: 10.1038/s41598-024-76903-y.
- 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.
Emmanuel CUELLAR, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Resectable Pancreatic Cancer, run by University Hospital, Toulouse 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 4 inclusion and 2 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 28 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 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?
Kinetic of circulating tumor DNA evaluation in resected pancreatic cancer. (time frame: Kinetic up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03435536, which also lists 1 linked publication.
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 28 Nov 2025.