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Cremona Population-Based Gastric Tumors Registry

This study is currently recruiting participants.
Verified March 2017 by Bianca Maria Donida, Ph.D, Istituti Ospitalieri di Cremona
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662739
First Posted: August 10, 2012
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Istituti Ospitalieri di Cremona
Azienda Sanitaria Locale di Cremona
Azienda Ospedaliera Ospedale Maggiore 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
  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: Epidemiological, Clinical and Pathological Characteristics of Gastric Tumors. The Population Based Specialized Registry in Northern Italy

Resource links provided by NLM:


Further study details as provided by Bianca Maria Donida, Ph.D, Istituti Ospitalieri di Cremona:

Primary Outcome Measures:
  • Collection of life-style, familiar, clinical, histological and biomolecular data [ Time Frame: Five Years ]

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

Other Outcome Measures:
  • Analysis of epidemiology, risk factors, family history and unidentified susceptibility genes and proteins [ Time Frame: Five Years ]

Biospecimen Retention:   Samples With DNA
Blood and Cancer Tissue Sample

Estimated Enrollment: 1000
Study Start Date: January 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662739


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

Locations
Italy
Medical Oncology Department of Istituti Ospitalieri di Cremona Recruiting
Cremona, Italy, 26100
Contact: Rodolfo Passalacqua, MD       r.passalacqua@asst-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 Ospedale Maggiore 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

Responsible Party: Bianca Maria Donida, Ph.D, PhD, Istituti Ospitalieri di Cremona
ClinicalTrials.gov Identifier: NCT01662739     History of Changes
Other Study ID Numbers: Donida-1
First Submitted: August 7, 2012
First Posted: August 10, 2012
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Bianca Maria Donida, Ph.D, Istituti Ospitalieri di Cremona:
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