NCT04429490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

January 21, 2026

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

June 10, 2020

Last Update Submit

January 19, 2026

Conditions

CarcinomaPancreatic Ductal

Keywords

Plant production productsrisk factoradipose tissueorganochlorinepesticides

Outcome Measures

Primary Outcomes (1)

  • Adipose tissue organochlorine concentration

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

    Day 0

Secondary Outcomes (1)

  • Urine organochlorine concentration

    Day 0

Study Arms (2)

Group "Cases"

EXPERIMENTAL

patients with pancreatic adenocarcinoma

Other: Adipose tissue sampling during surgery and urine sampling

Group "Controls"

OTHER

patients without pancreatic adenocarcinoma

Other: Adipose tissue sampling during surgery and urine sampling

Interventions

Adipose tissue sampling during surgery and urine samplingOTHER

Adipose tissue sampling during surgery and urine sampling

Group "Cases"Group "Controls"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases :
  • patients diagnosed with a pancreatic adenocarcinoma, all stages allowed
  • undergoing a surgery allowing to take a 10 grams adipose tissue sample
  • Controls :
  • undergoing a surgery allowing to take a 10 grams adipose tissue sample

You may not qualify if:

  • 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 :
  • no surgery allowing to take a 10 grams adipose tissue sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • Brugel M, Callon S, Carlier C, Amroun KL, Botsen D, Kianmanesh R, Perrier M, Piardi T, Renard Y, Rhaiem R, El Balkhi S, Bouche O. Association between pancreatic adenocarcinoma risk and concentration of organochlorine pesticides in adipose tissue and urine: A targeted-screening analysis case-control study (PESTIPAC). United European Gastroenterol J. 2024 Sep;12(7):951-959. doi: 10.1002/ueg2.12602. Epub 2024 Aug 8.

    PMID: 39118264RESULT

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

June 12, 2020

Primary Completion

February 15, 2023

Study Completion

May 15, 2023

Last Updated

January 21, 2026

Record last verified: 2024-10

Locations

FR(1)