Population-Based Stomach Cancer Registry (GCR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Medicina e Arte Onlus
Sponsor:
Collaborators:
Istituti Ospitalieri di Cremona
Azienda Sanitaria Locale di Cremona
Azienda Ospedaliera di Crema
Casa di Cura Figlie di San Camillo di Cremona
Casa di Cura San Camillo di Cremona
Casa di Cura Ancelle della Carità di Cremona
Information provided by (Responsible Party):
Bianca Maria Donida, Ph.D, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier:
NCT01662739
First received: August 7, 2012
Last updated: July 11, 2014
Last verified: August 2012
  Purpose

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.


Condition Intervention
Gastric Cancer
Behavioral: Questionnaire

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Medicina e Arte Onlus:

Primary Outcome Measures:
  • Collection of life-style, familiar, clinical, histological and biomolecular data [ Time Frame: Five Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collection of biological samples (blood and cancer tissue samples) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • 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

Blood and Cancer Tissue Sample


Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gastric Cancer

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662739

Contacts
Contact: Rodolfo Passalacqua, MD r.passalacqua@ospedale.cremona.it

Locations
Italy
Medical Oncology Department of Istituti Ospitalieri di Cremona Recruiting
Cremona, Italy, 26100
Contact: Rodolfo Passalacqua, MD       r.passalacqua@ospedale.cremona.it   
Principal Investigator: Rodolfo Passalacqua, MD         
Sponsors and Collaborators
Medicina e Arte Onlus
Istituti Ospitalieri di Cremona
Azienda Sanitaria Locale di Cremona
Azienda Ospedaliera di Crema
Casa di Cura Figlie di San Camillo di Cremona
Casa di Cura San Camillo di Cremona
Casa di Cura Ancelle della Carità di Cremona
  More Information

No publications provided

Responsible Party: Bianca Maria Donida, Ph.D, Study Coordinator , Medical Oncology Department, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier: NCT01662739     History of Changes
Other Study ID Numbers: Donida-1
Study First Received: August 7, 2012
Last Updated: July 11, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Medicina e Arte Onlus:
Population-Based Cancer Registry
Stomach
Epidemiology
Risk Factor
Biomolecular Features

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 22, 2014