Population-Based Stomach Cancer Registry (GCR)
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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. |
- Collection of life-style, familiar, clinical, histological and biomolecular data [ Time Frame: Five Years ] [ Designated as safety issue: No ]
- Collection of biological samples (blood and cancer tissue samples) [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]
- 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 |
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
Inclusion Criteria:
- Mentally competent and able to provide informed consent
Exclusion Criteria:
- Not Resident in Cremona province at diagnosis
Contacts and Locations| Contact: Rodolfo Passalacqua, MD | r.passalacqua@ospedale.cremona.it |
| Italy | |
| Istituti Ospitalieri di Cremona | Recruiting |
| Cremona, Italy, 26100 | |
| Contact: Rodolfo Passalacqua, MD r.passalacqua@ospedale.cremona.it | |
| Principal Investigator: Rodolfo Passalacqua, MD | |
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:
|
Adenocarcinoma Adenocarcinoma, Mucinous Adenocarcinoma, Papillary Carcinoma Cystadenocarcinoma 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 May 19, 2013