PARA (Pancreatic Adenocarcinoma Etiology: Role of Asbestos) Study of Risk Factors for Exocrine Pancreatic Neoplasms.

NCT06815172 | Active Not Recruiting

• 2 other identifiers: PARARC-2022-2773381
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study will be to evaluate the possible association between asbestos exposure (occupational, paraoccupational, environmental and non-occupational) and pancreatic adenocarcinoma. The data collected will be used to generate specific hypotheses on the possible environmental and occupational determinants of the disease. The study aims to evaluate:

1. 1.To evaluate the exposure to asbestos occurred during life, through the use of a standardized questionnaire to be administered to incident cases (newly diagnosed) of histologically diagnosed pancreatic adenocarcinoma afferent to the Medical Oncology Unit Prof. Ardizzoni in Group A, the exposure to asbestos occurred during the course of life;
2. 2.To produce quantitative estimates of the risk of pancreatic adenocarcinoma associated with asbestos exposure.

Conditions

Pancreatic Adenocarcinoma

Keywords

asbesto; cancer; risk factor; pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• primary objective

  The primary objective of the study will be to evaluate the possible association between asbestos exposure (occupational, paraoccupational, environmental and non-occupational) and pancreatic adenocarcinoma. The data collected will be used to generate specific hypotheses on the possible environmental and occupational determinants of the disease.

  From enrollment to the administration of the standardized questionnaire (once per patient), containing questions from the ReNaM (National Mesothelioma Registry) for up to 60 days.

Study Arms (2)

Group A

100 subjects will be patients seen on an outpatient basis and suffering from pancreatic adenocarcinoma with histological confirmation, contacted both during hospitalization and during outpatient access or in day service

Group B

400 subjects will be patients already included as controls in the CARA study (Cholangiocarcinoma Aetiology: Role of Asbestos - code 111/2013/UOSS evaluated in the meeting of the Ethics Committee of 19/11/2013) admitted to the Polyclinic in the ophthalmology, urology and gynecology departments not affected by the pathology under study, nor by pathologies associated with exposure to asbestos.

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The maximum duration of the enrollment period will be 32 years, in which 100 participants from Group A and 400 participants from Group B (previously enrolled in the CARA study (Cholangiocarcinoma Aetiology: Role of Asbestos - Study of risk factors of biliary neoplasms) with code 111/2013/UOSS evaluated in the meeting of the Ethics Committee on 19/11/2013 will be recruited. In each case, four hospital checks will be matched, in frequency matching by sex and five-year age group. The choice of this ratio between Group A and Group B (1:4) is justified by the desire to maximize the statistical power of the study.

You may qualify if:

• Incident cases (new diagnosis) of histologically diagnosed pancreatic adenocarcinoma afferent to the Medical Oncology Unit Prof. Ardizzoni
• Age 30-90 years
• Ability to complete the questionnaire
• Ability to read and understand Italian
• Signing the informed consent form

You may not qualify if:

• \. Prevalent cases of the pathology under study
• Group B
• Patients admitted to the S.Orsola-Malpighi Polyclinic in the ophthalmology, gynecology and urology departments with a diagnosis of cataracts, uterine fibroids and prostate adenoma previously included in the CARA study.
• Age 30-90 years
• Ability to complete the questionnaire
• Ability to read and understand Italian
• Signing the informed consent form
• Patients with pancreatic adenocarcinoma
• Patients with a history of malignant neoplastic pathologies
• Patients suffering from diseases associated with exposure to asbestos: pleuropatias (parietal plaques, diffuse visceral thickening, recurrent effusions and round atelectasis) and pulmonary diseases (alveolitis and asbestosis)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator

Study Sites (1)

Irccs Aoubo

Bologna, Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue sample

MeSH Terms

Conditions

Neoplasms

Study Officials

• GIOVANNI BRANDI, MD, PHD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 7, 2025
• Study Start: May 28, 2020
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-12

Locations

IT (1)