Population-Based Stomach Cancer Registry
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Population-Based Cancer Registry, Stomach, Epidemiology, Risk Factor, Biomolecular Features
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Questionnaire
Type: Behavioral
Overall Status
Recruiting
Summary
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.
Detailed Description
Background: GC is the 2nd and the 4th leading cause of cancer death in the world in male (M) and female (F) respectively. Worldwide there's a marked geographic variation in incidence and outcome. In Italy Cremona is characterized by the highest mortality rate.

Methods: On March 31, 2014 this observational study registered all cases of stomach or gastro-esophageal junction (GEJ) tumor diagnosed in Cremona province from 01/01/2010 to 12/31/2012. Data were collected following AIRTum (Associazione Italiana Registri Tumori) and IARC (International Agency for Research on Cancer) cancer registration recommendations. TNM and tumour site classification was according to AJCC/UICC 7th ed.; morphology according to Lauren classification and hereditary cases according to International GC Linkage Consortium guidelines. Survival analysis was performed using Kaplan-Meier method and curves were compared by Log Rank Test. Age incidence rates were calculated per 100,000 and standardized at European standard population.

Results: 448 cases were registered (M : F = 1.4 : 1) for a total resident population of 363,606 corresponding to an incidence rate of 31.2 for M and 15.2 for F compared to national rates of 22.6 and 11.8 respectively. Median age (interquartile range) was 75 (67 - 81) : 73 (64 - 79) for M and 78 (70 - 83) for F. M were younger than F at diagnosis (Mann Whitney Test). Cumulative risk by age of 84 was 5.2% for M and 2.6% for F. Median survival was 13.9 months (CI 95% 10,6 - 18,4) and there were no differences by sex (M: 11.33 CI 9.4 - 15.4 and F: 18.7 CI 11.7 - 24.2). Only 185 (41.3%) patients were submitted to surgery; pathological stage was I in 21%, II in 29% , III in 45%, IV in 5% . Diagnosis tumor site was GEJ in 15%, fundus - body in 45%, antrum - pylorus in 40%. Adenocarcinoma represented 95% of all cases, with 63% intestinal, 20% signet ring cell and 12% mixed-type. In 16% of gastric healthy mucosa H. Pylori infection was present and about 20% of tumor tissue showed HER-2 over - expression.

Conclusions: Incidence of GC in Cremona is higher than in the rest of the nation and 1 / 20 male is at risk to develop GC by the age of 84. The causes are not known at this time. Data collection is still ongoing in order to plan preventive strategies in this high risk area.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: PATIENTS ELEGIBILY : Any patients age at GC cancer diagnosis was included. Male and female patients were either included. Healthy volunteers were not included. At the time of diagnosis of cancer patients must be a province of Cremona inhabitants (districts of Crema, Cremona or Casalmaggiore). Informed consent signature was required.

TUMOR ELEGIBLY: Diagnosis must be performed from 2010 Juanuary, the 1st to 2013 December, 31st .The diagnosis must be of a infiltrating malignant tumor. The diagnosis should be of a primary tumor. Precancerous diagnosis were not considered. Recidivate tumor were not considered. The site of localization of the tumor at diagnosis must be stomach or gastro - esophageal junction as site of tumor onset.

HDGC ELEGIBILY : Gastric cancer is a known manifestation of inherited cancer predisposition syndromes similar to hereditary nonpolyposis colon cancer and Li-Fraumeni syndrome. According to the OMIM database, more than 90 per cent of gastric cancers are sporadic, whereas less than 10 per cent are hereditary (HDGC). Germline E-cadherin inactivating mutations in the CDH1 gene are responsible for the development of GC in approximately 30% of families with the hereditary diffuse gastric cancer syndrome (HDGC). Diagnostic criteria for HDGC are formulated by the International Gastric Cancer Linkage Consortium in 1999 and then they are reviewed in 2010. In order to individuate HDGC case and to included them in a specialist counselling and CDH-1 gene mutation evaluation, criteria by International GC Linkage Consortium 2010 guidelines were followed.
Location
Medical Oncology Department of Istituti Ospitalieri di Cremona
Cremona, Italy
Status: Recruiting
Contact: Rodolfo Passalacqua, MD - r.passalacqua@ospedale.cremona.it
Start Date
January 2010
Sponsors
Medicina e Arte Onlus
Source
Medicina e Arte Onlus
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page