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

August 7, 2012
September 12, 2012
January 2010
December 2015   (final data collection date for primary outcome measure)
Collection of life-style, familiar, clinical, histological and biomolecular data [ Time Frame: Five Years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01662739 on ClinicalTrials.gov Archive Site
Collection of biological samples (blood and cancer tissue samples) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]
Not Provided
Analysis of epidemiology, risk factors, family history and unidentified susceptibility genes and proteins [ Time Frame: Five Years ] [ Designated as safety issue: No ]
Not Provided
 
Population-Based Stomach Cancer Registry
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and Cancer Tissue Sample

Non-Probability Sample
  • 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
  • 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
Reisdent in Cremona
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mentally competent and able to provide informed consent

Exclusion Criteria:

  • Not Resident in Cremona province at diagnosis
Both
Not Provided
No
Contact: Rodolfo Passalacqua, MD r.passalacqua@ospedale.cremona.it
Italy
 
NCT01662739
Donida-1
Yes
Bianca Maria Donida, Ph.D, Istituti Ospitalieri di Cremona
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
Not Provided
Medicina e Arte Onlus
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP