PARA (Pancreatic Adenocarcinoma Etiology: Role of Asbestos): Study of Risk Factors for Exocrine Pancreatic Neoplasms.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- primary objective
研究概览
简要总结
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:
- 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;
- 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.
详细描述
Pancreatic adenocarcinoma (PDAC) ranks fourth among the causes of cancer death in Western countries, with an incidence almost comparable to mortality. The only therapeutic option with curative intent is surgery, but about 80% of subjects diagnosed with this neoplasm are not candidates for surgery due to the presence of distant metastases (stage IV according to the TNM system) or in the case of locally advanced disease (stage III), with an overall survival at 5 years of less than 10%.
Numerous risk factors have been related to the genesis of PDAC both environmental and genetic.
Environmental factors include cigarette smoking, dietary habits such as high intake of animal proteins and fats, high salt consumption, dehydrated foods, smoked meat, fried foods and smoked sugar, obesity, consumption of high amounts of alcohol, occupational exposure to chlorinated hydrocarbons, chronic pancreatitis and type II diabetes mellitus.
However, most of them are non-specific and there is often no concordance between the different studies conducted to evaluate them.
The role of asbestos exposure as an environmental risk factor in the etiopathogenesis of pancreatic cancer has been poorly investigated to date and with discordant results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prevalent cases of the pathology under study
- •Inclusion 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
- •Exclusion Criteria:
- •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)
- •Patients in danger of life or hospitalized waiting to undergo surgery for pathologies other than those of inclusion
结局指标
主要结局
primary objective
时间窗: 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.
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.
次要结局
未报告次要终点