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Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma (PESTIPAC)

C

CHU de Reims

Status

Completed

Conditions

Pancreatic Ductal
Carcinoma

Treatments

Other: Adipose tissue sampling during surgery and urine sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT04429490
PA20035

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

Group "Cases"
Experimental group
Description:
patients with pancreatic adenocarcinoma
Treatment:
Other: Adipose tissue sampling during surgery and urine sampling
Group "Controls"
Other group
Description:
patients without pancreatic adenocarcinoma
Treatment:
Other: Adipose tissue sampling during surgery and urine sampling

Trial contacts and locations

1

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Central trial contact

Olivier BOUCHE

Data sourced from clinicaltrials.gov

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