Study of Occupational Risk Factors for Biliary and Pancreatic Cancers

Brief summary public domain (ClinicalTrials.gov)

PANTOXBIL is a research project developed in the context of the increasing incidence of biliary tract and pancreatic cancers in France. Despite recent therapeutic advances, the prognosis of these cancers remains poor. Known risk factors do not fully explain the increase in incidence observed over recent decades. This suggests the possible role of emerging occupational and environmental risk factors, as reported in several epidemiological studies. The PANTOXBIL study is based on the analysis of detailed curriculum laboris data (employment periods, occupations, tasks performed, and occupational exposures) collected during two multicenter phase II clinical trials, TEDOPAM and IMMUNOBIL, conducted between 2018 and 2021 in patients with pancreatic and biliary tract cancers. An occupational exposure assessment was performed to calculate semi-quantitative cumulative exposure indices for each exposure or group of exposures for every participant. These indices will be compared with those of healthy controls from the CHOPPI cohort, initially designed to study occupational risk factors in COPD. PANTOXBIL is a matched case-control study based on sex, age, and smoking status. The aim is to compare cumulative occupational exposure indices between cases and controls in order to generate new hypotheses regarding occupational risk factors for biliary tract and pancreatic cancers.

Detailed description public domain (ClinicalTrials.gov)

Biliary tract and pancreatic cancers are a major public health issue because of their increasing incidence and poor prognosis, with an overall 5-year survival rate of approximately 10%. In France, the incidence of pancreatic cancer has increased markedly since 1990, with an estimated rise of nearly 300%, representing approximately 16,000 new cases in 2023. The incidence of cholangiocarcinoma, particularly intrahepatic cholangiocarcinoma, is also increasing. Although several risk factors have been identified, including smoking, alcohol consumption, diabetes, overweight/obesity, and chronic liver diseases, these factors do not fully explain the magnitude of the observed increase, especially in younger populations. These observations suggest the involvement of emerging occupational and environmental risk factors that remain insufficiently characterized. PANTOXBIL is a first step in the investigation of occupational risk factors for biliary tract and pancreatic cancers. The project is based on an epidemiological analysis of occupational exposures using curriculum laboris data collected in two multicenter phase II clinical trials conducted by GERCOR (TEDOPAM and IMMUNOBIL), including patients with biliopancreatic cancers. Both trials included detailed collection of occupational history, smoking habits, occupational tasks, and occupational exposures. TEDOPAM and IMMUNOBIL included 136 and 206 patients, respectively. Among them, 70 patients with biliary tract or pancreatic cancers completed an exploitable curriculum laboris and will be included as cases in this study. After detailed analysis of the curriculum laboris data, a semi-quantitative cumulative occupational exposure index will be calculated for each participant by integrating exposure frequency, intensity, probability, and duration. Each case will be matched with two healthy controls from the CHOPPI cohort (n = 140) according to sex, age, and smoking status. Primary Objective To generate hypotheses regarding occupational exposures potentially associated with biliary tract and pancreatic cancers using a case-control analysis based on curriculum laboris data. Secondary Objective To evaluate the feasibility and relevance of integrating curriculum laboris data into digestive oncology clinical trials. The following data will be collected: * Age * Sex * Smoking status: current smoker, former smoker (cessation \>1 year), non-smoker * Tobacco exposure in pack-years * Alcohol consumption in g/L when available * Body mass index (BMI) in kg/m² * Medical history including diabetes, hypertension, dyslipidemia, chronic liver disease, and associated etiologies when available * HBV, HCV, and HIV serological status when available * Detailed curriculum laboris All data will be collected and analyzed in a pseudonymized form to ensure participant confidentiality.