PARA (Pancreatic Adenocarcinoma Etiology: Role of Asbestos) Study of Risk Factors for Exocrine Pa… (NCT06815172) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PARA (Pancreatic Adenocarcinoma Etiology: Role of Asbestos) Study of Risk Factors for Exocrine Pancreatic Neoplasms.
Italy500 participantsStarted 2020-05-28
Plain-language 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. 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. To produce quantitative estimates of the risk of pancreatic adenocarcinoma associated with asbestos exposure.
2.3. To evaluate the presence of asbestos fibers directly on histological sections of pancreatic cancer of patients exposed to asbestos and undergoing surgery.
Who can participate
Age range30 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
primary objective
Timeframe: 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.
Trial details
NCT IDNCT06815172
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
✕. 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)