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Trial Title:
Cremona Population-Based Gastric Tumors Registry
NCT ID:
NCT01662739
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Population-Based Cancer Registry
Stomach
Epidemiology
Risk Factor
Biomolecular Features
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Questionnaire
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.
Detailed description:
Background: Gastric cancer (GC) is the 5th most common cancer and the 3rd leading cause
of cancer-related deaths worldwide. GC incidence and mortality rates vary widely across
different geographical areas. In Italy the province of Cremona is characterized by an
high incidence, compared with the national one. For these reason a specialized population
based registry was set up.
Methods: Up to now the collection encompasses all the GC cases diagnosed in Cremona
province from January 1st 2010 until December 31st 2015. The main data sources were
represented by the pathological records and the patient clinical charts. Data were
collected following AIRTum (Associazione Italiana Registri Tumori) and IARC
(International Agency for Research on Cancer) cancer registration recommendations.
Territory of Cremona province comprises 3 main public hospitals and 3 private structures.
All of them refer to 2 pathology services. All these facilities were involved in the
project. A minority of patients usually ask for different surgery and move to neighboring
provinces, mainly Milan and Brescia. An official collaboration with these facilities was
signed in order to have the access to the data of their patients who were inhabitants of
the province of Cremona. A multidisciplinary team of clinicians (oncologists,
gastroenterologists, general practitioners, surgeons), pathologists, geneticists and
methodologists (epidemiologists, hygienists) was involved in the project.
The registration of an incident case usually began with the pathological confirmation of
diagnosis of cancer. Subsequently, medical records were obtained. For each case the
following variables were registered: personal and familiar data; imaging studies
performed; details on surgery and other treatments received; host genetic background and
biomolecular characteristic, social and environmental factors. All data were collected,
recorded, protected and processed in accordance to AIRTum-IARC (International Agency for
Research on Cancer) cancer registration recommendations and national privacy laws.
Any age at diagnosis was included. At the time of diagnosis patients had to be
inhabitants of the province of Cremona (districts of Crema, Cremona or Casalmaggiore).
Only diagnoses of primary gastric neoplasms were considered. Precancerous lesions and
relapsed tumor diagnoses were not considered. For the specific purposes of our study, we
didn't record cases diagnosed based on Death Certificate Only (DCO)"in situ" tumors were
also included.
Site of the tumor at diagnosis was stomach or gastro-esophageal junction (GEJ), ref. cod.
ICD-X C16, according to the UICC, 7th ed.
All gastric malignancies were considered: gastric cancer; lymphoma; sarcoma and GIST.
Gastric cancer was classified according to the Lauren's classification system, which
distinguishes two main histological types: "intestinal" and "diffuse" . "Mixed" gastric
carcinomas composed of intestinal and diffuse components have also been identified.
The primary tumor location was divided into three groups in consideration not only of the
oncological but also of the surgical approach. Such groups were 1) GEJ-cardia; 2)
body-fundus; 3) antrum-pylorus-angulus.
The TNM classification was recorded and the corresponding pathological stage was
determined according to the 7th edition of the Union for International Cancer Control
(UICC) and hereditary cases according to International GC Linkage Consortium guidelines.
Evaluation of the infection of Helicobacter pylori (HP) was performed by
immunohistochemistry (IHC) in health gastric mucosa using the GIEMSA stain method. The
HER-2 oncogene overexpression was evaluated in tumour gastric mucosa by the IHC method
Dako Hercept TestTM. Results were confirmed by Fluorescent in Situ Hybridization (FISH)
when IHC positivity score was 2.
To individuate Hereditary Diffuse Gastric Cancer (HDGC) cases, criteria by International
GC Linkage Consortium 2010 guidelines were followed.
Incidence, standard errors, and 95% confidence intervals (CI) were calculated according
to the International Agency for Research on Cancer (IARC) general guidelines. As for CIs,
the method that considered the approximation to the Poisson distribution was chosen.
Age-specific incidence rates were stratified into 18 subgroups by 5-year age interval (0
- 4, to 85+ years). Raw age-specific (5-years classes) and age-standardised
(age-adjusted) rates were calculated per 100,000 inhabitants. For raw rates the
denominator was the resident population census at 31st December of each year, available
online at the official site of Cremona province. An age-standardized rate (ASR) is a
weighted average of the age-specific (raw) rate, where the weight is the proportion of
individuals in the corresponding age group of a standard population. Age-standardised
rates were calculated using the standard age-structure of the European (EU) and World (W)
standard population. This corrects the potential confounding effect derived from the
differences in age between different populations. The trend of incidence, expressed as
"Annual Percent Change" (APC) was evaluated using Join Point (National Cancer Institute,
Bethesda, MD) in order to identify significant changes. Overall survival analysis was
carried out by Kaplan-Meier methods and statistically significant differences were
evaluated by Log-Rank Test . Survival hazard ratio was evaluated by Cox regression model,
subsequently the testing of the proportion of hazard. Cumulative risks and other
variables, including age at diagnosis, anatomical subsite, morphology of the tumour, TNM
stage at diagnosis, presence of HP infection, HER-2 amplification status, 5-year survival
and 1-year mortality rate were reported too. Descriptive statistics were used to
summarize the data and parametric and non-parametric tests were used to evaluate
differences between groups. Statistical analysis was carried out by STATA 13 software
package (Texas, USA). A p-value less than 0.05 vas considered as statistically
significant.
Criteria for eligibility:
Study pop:
Gastric Cancer
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Oncology Department of Istituti Ospitalieri di Cremona
Address:
City:
Cremona
Zip:
26100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Rodolfo Passalacqua, MD
Email:
r.passalacqua@asst-cremona.it
Investigator:
Last name:
Rodolfo Passalacqua, MD
Email:
Principal Investigator
Start date:
January 2010
Completion date:
December 2018
Lead sponsor:
Agency:
Medicina e Arte Onlus
Agency class:
Other
Collaborator:
Agency:
Istituti Ospitalieri di Cremona
Agency class:
Other
Collaborator:
Agency:
Azienda Sanitaria Locale di Cremona
Agency class:
Other
Collaborator:
Agency:
Azienda Ospedaliera Ospedale Maggiore di Crema
Agency class:
Other
Collaborator:
Agency:
Casa di Cura Figlie di San Camillo di Cremona
Agency class:
Other
Collaborator:
Agency:
Casa di Cura San Camillo di Cremona
Agency class:
Other
Collaborator:
Agency:
Casa di Cura Ancelle della Carità di Cremona
Agency class:
Other
Source:
Medicina e Arte Onlus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01662739