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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04429490
Other study ID # PA20035
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 12, 2020
Est. completion date September 12, 2023

Study information

Verified date September 2021
Source CHU de Reims
Contact Olivier BOUCHE
Phone 03 26 78 31 13
Email obouche@chu-reims.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date September 12, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Adipose tissue sampling during surgery and urine sampling
Adipose tissue sampling during surgery and urine sampling

Locations

Country Name City State
France Damien JOLLY Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adipose tissue organochlorine concentration QuEChERS method to extract organochlorines Use of Agilent 7010 Detection limit : 10ng/g of adipose tissue Day 0
Secondary Urine organochlorine concentration Use of Agilent 7010 Detection limit : 0.1microg/L Day 0
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