Population-Based Stomach Cancer Registry (GCR)

This study is currently recruiting participants.
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: September 12, 2012
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.


Condition Intervention
Primary Stomach Carcinoma:
Adenocarcinoma
Papillary Adenocarcinoma
Tubular Adenocarcinoma
Mucinous Adenocarcinoma
Signet-ring Cell Carcinoma
Adenosquamous Carcinoma
Squamous Cell Carcinoma
Small Cell Carcinoma
Undifferentiated Carcinoma
Other (Specify)
Or Primary:
Esophagogastric Junction Carcinoma
Neuroendocrine Tumors
GiST
LNH
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)
Groups/Cohorts Assigned Interventions
Reisdent in Cremona Behavioral: Questionnaire

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Primary Stomach Carcinoma (WHO Classification, 7th Ed.)

    • Adenocarcinoma (Intestinal type; Diffuse type)
    • Papillary adenocarcinoma
    • Tubular adenocarcinoma
    • Mucinous adenocarcinoma (> 50% mucinous)
    • Signet-ring cell carcinoma (> 50% signet-ring cells)
    • Adenosquamous carcinoma
    • Squamous cell carcinoma
    • Small cell carcinoma
    • Undifferentiated carcinoma
    • Other (specify) Or primary
    • Esophagogastric junction carcinoma
    • Neuroendocrine tumors
    • GiST
    • LNH
  • Patients Cremona's province residence at diagnosis
Criteria

Inclusion Criteria:

  • Mentally competent and able to provide informed consent

Exclusion Criteria:

  • Not Resident in Cremona province at diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662739

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

Locations
Italy
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, Bianca Maria Donida, 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: September 12, 2012
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:
Cystadenocarcinoma
Adenocarcinoma
Adenocarcinoma, Papillary
Carcinoma
Adenocarcinoma, Mucinous
Carcinoma, Squamous Cell
Stomach Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carcinoma, Adenosquamous
Carcinoma, Signet Ring Cell
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014