Cremona Population-Based Gastric Tumors Registry

NCT01662739 | Unknown DMC

• 1 other identifier: Donida-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

Population-Based Cancer Registry; Stomach; Epidemiology; Risk Factor; Biomolecular Features

Outcome Measures

Primary Outcomes (1)

• Collection of life-style, familiar, clinical, histological and biomolecular data

  Five Years

Secondary Outcomes (1)

• Collection of biological samples (blood and cancer tissue samples)

  Five Years

Other Outcomes (1)

• Analysis of epidemiology, risk factors, family history and unidentified susceptibility genes and proteins

  Five Years

Interventions

Questionnaire BEHAVIORAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric Cancer

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.

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Sponsors & Collaborators

• Medicina e Arte Onlus: lead
• Istituti Ospitalieri di Cremona: collaborator
• Azienda Sanitaria Locale di Cremona: collaborator
• Azienda Ospedaliera Ospedale Maggiore di Crema: collaborator
• Casa di Cura Figlie di San Camillo di Cremona: collaborator
• Casa di Cura San Camillo di Cremona: collaborator
• Casa di Cura Ancelle della Carità di Cremona: collaborator

Study Sites (1)

Medical Oncology Department of Istituti Ospitalieri di Cremona

Cremona, Cremona, 26100, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Cancer Tissue Sample

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Rodolfo Passalacqua, MD

CONTACT

r.passalacqua@asst-cremona.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 10, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

IT (1)