Epidemiological, Clinical and Pathological Characteristics of Gastric Tumors. The Population Based Specialized Registry in Northern Italy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Collection of life-style, familiar, clinical, histological and biomolecular data
研究概览
简要总结
Gastric cancer remains one of the leading causes of cancer-related deaths worldwide. There is difference between different countries in the world in the incidence and outcome. Also Italy on its inside shows a variability between regions and Lombardy hold the most incidence and mortality Italian rate, with the province of Cremona as one of the leading area with its gastric cancer mortality rate. (http://www.aslcremona.it/html/atlante/introduzione.htm). Tumor specialized registry can be viewed as one of the main strategies for studying and monitoring the impact of an important cancer diagnosis. In addition the information obtained from it can be translated into preventive measures and health surveillance that might lead to a better control of this tumor in a province with a so high mortality rate. Project purpose is to define the incidence of gastric cancer in the province of Cremona and the correlation with environmental, familiar, genetic and social factors; to adopt prevention strategies to reduce the impact of the disease and to create a gastric cancer bio-bank, including blood and tissue samples, for collaborative research projects regarding molecular and cellular aspects of gastric cancer.
详细描述
Background: Gastric cancer (GC) is the 5th most common cancer and the 3rd leading cause of cancer-related deaths worldwide. GC incidence and mortality rates vary widely across different geographical areas. In Italy the province of Cremona is characterized by an high incidence, compared with the national one. For these reason a specialized population based registry was set up.
Methods: Up to now the collection encompasses all the GC cases diagnosed in Cremona province from January 1st 2010 until December 31st 2015. The main data sources were represented by the pathological records and the patient clinical charts. Data were collected following AIRTum (Associazione Italiana Registri Tumori) and IARC (International Agency for Research on Cancer) cancer registration recommendations. Territory of Cremona province comprises 3 main public hospitals and 3 private structures. All of them refer to 2 pathology services. All these facilities were involved in the project. A minority of patients usually ask for different surgery and move to neighboring provinces, mainly Milan and Brescia. An official collaboration with these facilities was signed in order to have the access to the data of their patients who were inhabitants of the province of Cremona. A multidisciplinary team of clinicians (oncologists, gastroenterologists, general practitioners, surgeons), pathologists, geneticists and methodologists (epidemiologists, hygienists) was involved in the project.
The registration of an incident case usually began with the pathological confirmation of diagnosis of cancer. Subsequently, medical records were obtained. For each case the following variables were registered: personal and familiar data; imaging studies performed; details on surgery and other treatments received; host genetic background and biomolecular characteristic, social and environmental factors. All data were collected, recorded, protected and processed in accordance to AIRTum-IARC (International Agency for Research on Cancer) cancer registration recommendations and national privacy laws.
Any age at diagnosis was included. At the time of diagnosis patients had to be inhabitants of the province of Cremona (districts of Crema, Cremona or Casalmaggiore). Only diagnoses of primary gastric neoplasms were considered. Precancerous lesions and relapsed tumor diagnoses were not considered. For the specific purposes of our study, we didn't record cases diagnosed based on Death Certificate Only (DCO)"in situ" tumors were also included.
Site of the tumor at diagnosis was stomach or gastro-esophageal junction (GEJ), ref. cod. ICD-X C16, according to the UICC, 7th ed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Collection of life-style, familiar, clinical, histological and biomolecular data
时间窗: Five Years
次要结局
- Collection of biological samples (blood and cancer tissue samples)(Five Years)
研究者
Bianca Maria Donida, Ph.D
PhD
Istituti Ospitalieri di Cremona
