Study of Occupational Risk Factors for Biliary and Pancreatic Cancers

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.

Inclusion criteria

• Cases :

• Patients included in the TEDOPAM or IMMUNOBIL trials
• Diagnosis of biliary tract or pancreatic cancer
• Completed and exploitable curriculum laboris
• Controls :

• Subjects from the CHOPPI cohort
• Age ≥ 18 years
• No biliary tract or pancreatic cancer
• No known familial predisposition to biliary tract or pancreatic cancers
• No opposition to data reuse

Exclusion criteria

• Incomplete or non-exploitable occupational history
• Refusal of data reuse