CarcinomaPESTIPACNCT04429490
Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma
A study testing Adipose tissue sampling during surgery and urine sampling in people with Carcinoma and Pancreatic Ductal, run by CHU de Reims at 1 site in France.
Trial summary
Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in Grand Est region. National incidence has doubled for men and tripled for women between 1982 and 2012. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Adipose tissue sampling during surgery and urine sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 15 May 2023
- 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
- Cases :
- patients diagnosed with a pancreatic adenocarcinoma, all stages allowed
- undergoing a surgery allowing to take a 10 grams adipose tissue sample
- Controls :
- patients without a pancreatic neoplasm on a 6 months old CT scan before inclusion
- undergoing a surgery allowing to take a 10 grams adipose tissue sample
Who cannot join
- Cases :
- patients diagnosed with a pancreatic adenocarcinoma developed on IPMN or cystadenoma
- patient with a known genetic predisposition increasing pancreatic adenocarcinoma risk
- histopathology proof of a mixed neuroendocrine neoplasm
- no surgery allowing to take a 10 grams adipose tissue sample
- Controls :
- patients with a pancreatic neoplasm on a 6 months old CT scan before inclusion
- no surgery allowing to take a 10 grams adipose tissue sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.
Pancreatic adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in Grand Est region. National incidence has doubled for men and tripled for women between 1982 and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all stages 5-year survival. It will become the second deadliest in Europe, behind bronchopulmonary cancer.
Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or obesity. However, a mismatch exists between incidence forecasts and actual risk factors knowledge. Several hypothesis plead for an environnemental cause.
Read more
Plant protection products oncogenetic effects are known and have been proved to be responsible for tumors, including haematological malignancies. Its role in pancreatic carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to conclude for causality. Organochlorines is a specific subset of plant protection product that store in lipids during lifetime.
The aim is to study association between organochlorine concentration in adipose tissue with pancreatic adenocarcinoma.
Read the detailed description
Unicentric prospective case control study comparing organochlorine levels including patients diagnosed with a pancreatic adenocarcinoma undergoing a surgery allowing to collect an adipose tissue sample (10g).
Controls are adults with no pancreatic cancer (excluded by a 6 months old computed tomography excluding the probability of a pancreatic neoplasm), paired with cases upon age and body mass index, with a scheduled surgical procedure allowing to collect an adipose tissue sample without extending procedure length.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Adipose tissue sampling during surgery and urine sampling
- Keywords
- Plant production products, risk factor, adipose tissue, organochlorine, pesticides
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue sampling during surgery and urine samplingOther
Adipose tissue sampling during surgery and urine sampling
| Study group | Role | What they receive |
|---|---|---|
| Group "Cases" | Experimental | patients with pancreatic adenocarcinoma Receives: Other: Adipose tissue sampling during surgery and urine sampling |
| Group "Controls" | Other | patients without pancreatic adenocarcinoma Receives: Other: Adipose tissue sampling during surgery and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue organochlorine concentration
QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue
Measured: Day 0
Secondary outcomes (1)
Urine organochlorine concentration
Use of Agilent 7010 Detection limit : 0.1microg/L
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start12 Jun 2020
- Primary completion15 Feb 2023
- Study completion15 May 2023
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429490
- Sponsor's protocol ID
- PA20035
- Acronym
- PESTIPAC
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brugel M, Callon S, Carlier C, Amroun KL, Botsen D, Kianmanesh R, Perrier M, Piardi T, Renard Y, Rhaiem R, El Balkhi S, Bouche O. Association between pancreatic adenocarcinoma risk and concentration of organochlorine pesticides in adipose tissue and urine: A targeted-screening analysis case-control study (PESTIPAC). United European Gastroenterol J. 2024 Sep;12(7):951-959. doi: 10.1002/ueg2.12602. Epub 2024 Aug 8.
PubMed 39118264
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.
- ClinicalTrials.gov ID
- NCT04429490
- Acronym / sponsor ID
- PESTIPAC / PA20035
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- Plant production products, risk factor, adipose tissue, organochlorine, pesticides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 12 Jun 2020 (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 adenocarcinoma represents more than 90% of pancreatic neoplasms. Around 14000 new cases of pancreatic adenocarcinoma are being diagnosed each year in France and about 8.6% in Grand Est region. National incidence has doubled for men and tripled for women between 1982 and 2012. Pancreatic adenocarcinoma is the deadliest digestive cancer, with only 7 to 8% all stages 5-year survival. It will become the second deadliest in Europe, behind bronchopulmonary cancer.
Several risk factors have been identified such as diabetes, tobacco, chronic pancreatitis or obesity. However, a mismatch exists between incidence forecasts and actual risk factors knowledge. Several hypothesis plead for an environnemental cause.
Plant protection products oncogenetic effects are known and have been proved to be responsible for tumors, including haematological malignancies. Its role in pancreatic carcinogenesis is still poorly studied and show heterogeneous results. They do not allow to conclude for causality. Organochlorines is a specific subset of plant protection product that store in lipids during lifetime.
The aim is to study association between organochlorine concentration in adipose tissue with pancreatic adenocarcinoma.
Detailed description
Unicentric prospective case control study comparing organochlorine levels including patients diagnosed with a pancreatic adenocarcinoma undergoing a surgery allowing to collect an adipose tissue sample (10g).
Controls are adults with no pancreatic cancer (excluded by a 6 months old computed tomography excluding the probability of a pancreatic neoplasm), paired with cases upon age and body mass index, with a scheduled surgical procedure allowing to collect an adipose tissue sample without extending procedure length.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "Cases" | Experimental | Other: Adipose tissue sampling during surgery and urine samplingpatients with pancreatic adenocarcinoma |
| Group "Controls" | Other | Other: Adipose tissue sampling during surgery and urine samplingpatients without pancreatic adenocarcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients diagnosed with a pancreatic adenocarcinoma, all stages allowed
- undergoing a surgery allowing to take a 10 grams adipose tissue sample
- patients without a pancreatic neoplasm on a 6 months old CT scan before inclusion
- undergoing a surgery allowing to take a 10 grams adipose tissue sample
Key exclusion criteria (8 listed)
- patients diagnosed with a pancreatic adenocarcinoma developed on IPMN or cystadenoma
- patient with a known genetic predisposition increasing pancreatic adenocarcinoma risk
- histopathology proof of a mixed neuroendocrine neoplasm
- no surgery allowing to take a 10 grams adipose tissue sample
- patients with a pancreatic neoplasm on a 6 months old CT scan before inclusion
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 |
|---|---|---|
| Adipose tissue sampling during surgery and urine samplingAdipose tissue sampling during surgery and urine sampling | Other | Group "Cases", Group "Controls" |
Primary outcome
Adipose tissue organochlorine concentration
Time frame: Day 0
QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue
1 secondary outcome
Urine organochlorine concentration
Time frame: Day 0
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 21 Jan 2026.
- Results publication: PubMed 39118264Brugel M, Callon S, Carlier C, Amroun KL, Botsen D, Kianmanesh R, Perrier M, Piardi T, Renard Y, Rhaiem R, El Balkhi S, Bouche O. Association between pancreatic adenocarcinoma risk and concentration of organochlorine pesticides in adipose tissue and urine: A targeted-screening analysis case-control study (PESTIPAC). United European Gastroenterol J. 2024 Sep;12(7):951-959. doi: 10.1002/ueg2.12602. Epub 2024 Aug 8.
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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 Adipose tissue sampling during surgery and urine sampling in people with Carcinoma and Pancreatic Ductal, run by CHU de Reims 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 8 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 21 Jan 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?
Adipose tissue organochlorine concentration (time frame: Day 0). 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 NCT04429490, 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 21 Jan 2026.