Biliary Tract CancerPANTOXBILNCT07668024
Study of Occupational Risk Factors for Biliary and Pancreatic Cancers
An observational study of Biliary Tract Cancer and Pancreatic Cancer, run by Centre Hospitalier Intercommunal Creteil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Pancreatic Cancer
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic and biliary tract cancers included during two multicenter phase II clinical trials (cases) Control patients without pancreatic and biliary tract cancers from the CHOPPI cohort
Who may be able to join
- 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
Show all 10Show fewer
- Age ≥ 18 years
- No biliary tract or pancreatic cancer
- No known familial predisposition to biliary tract or pancreatic cancers
- No opposition to data reuse
Who cannot join
- Incomplete or non-exploitable occupational history
- Refusal of data reuse
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Biliary Tract Cancer, Pancreatic Cancer
- Keywords
- Biliopancreatic cancers, Occupational exposure, Cumulative exposure index, Curriculum laboris, Case-control study
- Medical subject headings
- Biliary Tract Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with biliary tract or pancreatic cancers | Patients included in the TEDOPAM or IMMUNOBIL trials diagnosis of biliary tract or pancreatic cancer | |
| Control patients | Subjects from the CHOPPI cohort without biliary tract or pancreatic cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the occupational exposure index to targeted toxicants
Compare the occupational exposure index to targeted toxicants, calculated from curriculum laboris, between patients with biliary-pancreatic cancers and controls without biliary-pancreatic cancers, in order to estimate for each toxicant an odds ratio and to identify occupational exposures potentially involved in the occurrence of these cancers
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Responsible party
- Sponsor
- Investigators
- Pascal ANDUJAR, MD, PhD, Principal investigator, Centre Hospitalier intercommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668024
- Sponsor's protocol ID
- PANTOXBIL
- Acronym
- PANTOXBIL
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Occupational Risk Factors for Biliary and Pancreatic Cancers
- ClinicalTrials.gov ID
- NCT07668024
- Acronym / sponsor ID
- PANTOXBIL / PANTOXBIL
- Conditions
- Biliary Tract Cancer, Pancreatic Cancer
- Keywords
- Biliopancreatic cancers, Occupational exposure, Cumulative exposure index, Curriculum laboris, Case-control study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with biliary tract or pancreatic cancers | – | –Patients included in the TEDOPAM or IMMUNOBIL trials diagnosis of biliary tract or pancreatic cancer |
| Control patients | – | –Subjects from the CHOPPI cohort without biliary tract or pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic and biliary tract cancers included during two multicenter phase II clinical trials (cases) Control patients without pancreatic and biliary tract cancers from the CHOPPI cohort
Key inclusion criteria (10 listed)
- Cases :
- Controls :
Key exclusion criteria (2 listed)
- Incomplete or non-exploitable occupational history
- Refusal of data reuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the occupational exposure index to targeted toxicants
Time frame: Day 1
Compare the occupational exposure index to targeted toxicants, calculated from curriculum laboris, between patients with biliary-pancreatic cancers and controls without biliary-pancreatic cancers, in order to estimate for each toxicant an odds ratio and to identify occupational exposures potentially involved in the occurrence of these cancers
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pascal ANDUJAR, MD, PhD principal investigator
Centre Hospitalier intercommunal de Créteil
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer and Pancreatic Cancer, run by Centre Hospitalier Intercommunal Creteil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pacsal ANDUJAR, MD, PhD (01 57 02 20 95 ext. +33, pascal.andujar@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the occupational exposure index to targeted toxicants (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.