Clinical trial NCT04429490: Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma
Official title: Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma
Pancreatic Ductal
Keywords: Plant production products
risk factor
adipose tissue
organochlorine
pesticides
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: inclusion criteria :

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

exclusion criteria :

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

Primary outcomes:
measure: Adipose tissue organochlorine concentration
timeFrame: Day 0
Secondary outcomes:
measure: Urine organochlorine concentration
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: