PESTIPAC: Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma

Sponsor
CHU de Reims (Other)
Overall Status
Recruiting
CT.gov ID
NCT04429490
Collaborator
(none)
56
1
2
39
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Adipose tissue sampling during surgery and urine sampling
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma : a Case Control Study.
Actual Study Start Date :
Jun 12, 2020
Anticipated Primary Completion Date :
Jun 12, 2023
Anticipated Study Completion Date :
Sep 12, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adipose tissue organochlorine concentration [Day 0]

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

Secondary Outcome Measures

  1. Urine organochlorine concentration [Day 0]

    Use of Agilent 7010 Detection limit : 0.1microg/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damien JOLLY Reims France

Sponsors and Collaborators

  • CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHU de Reims
ClinicalTrials.gov Identifier:
NCT04429490
Other Study ID Numbers:
  • PA20035
First Posted:
Jun 12, 2020
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHU de Reims
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021