Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma

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EstadoReclutamiento

Patrocinadores

CHU de Reims

ENSAYO CLÍNICO: NCT04429490

BioSeek: nct04429490

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez:	05/31/2020
Primero enviado:	06/09/2020
Inscripción estimada enviada:	06/09/2020
Publicado por primera vez:	06/11/2020
Última actualización enviada:	06/17/2020
Última actualización publicada:	06/17/2020
Fecha de inicio real del estudio:	06/11/2020
Fecha estimada de finalización primaria:	06/11/2022
Fecha estimada de finalización del estudio:	09/11/2022

Condición o enfermedad

Carcinoma

Pancreatic Ductal

Intervención / tratamiento

Other: Adipose tissue sampling during surgery and urine sampling

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Experimental: Group "Cases" patients with pancreatic adenocarcinoma
Other: Group "Controls" patients without pancreatic adenocarcinoma

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. Adipose tissue organochlorine concentration [Day 0]

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

Medidas de resultado secundarias

1. Urine organochlorine concentration [Day 0]

Use of Agilent 7010 Detection limit : 0.1microg/L

Organochlorine Concentration in Adipose Tissue and Pancreatic Adenocarcinoma

Palabras clave

nicotina

cáncer de páncreas

carcinogénesis

cáncer

adenocarcinoma

pancreatitis

obesidad