NCT07668024

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Progress14%
Aug 2026Sep 2026

First Submitted

Initial submission to the registry

June 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

1 month

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Keywords

Biliopancreatic cancersOccupational exposureCumulative exposure indexCurriculum laborisCase-control study

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Biliary Tract NeoplasmsPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Pascal ANDUJAR, MD, PhD

    Centre Hospitalier intercommunal de Créteil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pacsal ANDUJAR, MD, PhD

CONTACT

Camille JUNG, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 25, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06