Population-Based Stomach Cancer Registry (GCR)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Creation of a Population-Based Stomach Cancer Registry in the Cremona Province Area in Italy. Study of the Epidemiology, the Risk Factors and Clinical, Histological and Biomolecular Features of the Pathology.|
- Collection of life-style, familiar, clinical, histological and biomolecular data [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Collection of biological samples (blood and cancer tissue samples) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]
- Analysis of epidemiology, risk factors, family history and unidentified susceptibility genes and proteins [ Time Frame: Five Years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2010|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662739
|Contact: Rodolfo Passalacqua, MDfirstname.lastname@example.org|
|Medical Oncology Department of Istituti Ospitalieri di Cremona||Recruiting|
|Cremona, Italy, 26100|
|Contact: Rodolfo Passalacqua, MD email@example.com|
|Principal Investigator: Rodolfo Passalacqua, MD|