Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma (PESTIPAC)

September 27, 2021 updated by: CHU de Reims

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Reims, France
        • Recruiting
        • Damien JOLLY
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group "Cases"
patients with pancreatic adenocarcinoma
Other: Adipose tissue sampling during surgery and urine sampling
Adipose tissue sampling during surgery and urine sampling
Other: Group "Controls"
patients without pancreatic adenocarcinoma
Other: Adipose tissue sampling during surgery and urine sampling
Adipose tissue sampling during surgery and urine sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipose tissue organochlorine concentration
Time Frame: Day 0
QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine organochlorine concentration
Time Frame: Day 0
Use of Agilent 7010 Detection limit : 0.1microg/L
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Anticipated)

June 12, 2023

Study Completion (Anticipated)

September 12, 2023

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA20035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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