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Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma (PESTIPAC)

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Adipose tissue sampling during surgery and urine sampling
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Carcinoma focused on measuring Plant production products, risk factor, adipose tissue, organochlorine, pesticides

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group "Cases"

Group "Controls"

Arm Description

patients with pancreatic adenocarcinoma

patients without pancreatic adenocarcinoma

Outcomes

Primary Outcome Measures

Adipose tissue organochlorine concentration
QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue

Secondary Outcome Measures

Urine organochlorine concentration
Use of Agilent 7010 Detection limit : 0.1microg/L

Full Information

First Posted
June 10, 2020
Last Updated
September 27, 2021
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT04429490
Brief Title
Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma
Acronym
PESTIPAC
Official Title
Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 12, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
Plant production products, risk factor, adipose tissue, organochlorine, pesticides

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group "Cases"
Arm Type
Experimental
Arm Description
patients with pancreatic adenocarcinoma
Arm Title
Group "Controls"
Arm Type
Other
Arm Description
patients without pancreatic adenocarcinoma
Intervention Type
Other
Intervention Name(s)
Adipose tissue sampling during surgery and urine sampling
Intervention Description
Adipose tissue sampling during surgery and urine sampling
Primary Outcome Measure Information:
Title
Adipose tissue organochlorine concentration
Description
QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Urine organochlorine concentration
Description
Use of Agilent 7010 Detection limit : 0.1microg/L
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier BOUCHE
Phone
03 26 78 31 13
Ext
0033
Email
obouche@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOUCHE
Phone
03 26 78 31 13
Ext
0033
Email
obouche@chu-reims.fr

12. IPD Sharing Statement

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Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma

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