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Clinical Trials/NCT00582257
NCT00582257
Completed
Not Applicable

Early Onset and Familial Gastric Cancer Registry

Memorial Sloan Kettering Cancer Center10 sites in 2 countries971 target enrollmentDecember 13, 2005
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
971
Locations
10
Primary Endpoint
Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to establish a gastric cancer registry. A registry is a database of information. With the registry, we can learn more about the genetic causes of gastric cancer in order to develop better methods of early diagnosis, prevention, and treatment of gastric cancers. As part of this study, you will be asked to join a registry of families who are affected with various forms of gastric cancer. These registries are important because they may help physicians better manage gastric cancer now and in the future. Participating in the Early Onset and Familial Gastric Cancer Registry can also be educational for families, since it will provide important information to patients, families, and physicians. All of this will help to further our understanding of genetic causes of gastric cancer and eventually, help determine better ways to diagnose, treat, and survey patients with gastric cancer and people who may have a higher risk for gastric cancer.

Registry
clinicaltrials.gov
Start Date
December 13, 2005
End Date
September 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient/Relative Cohort:
  • Must meet one or more criteria below:
  • A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution.
  • A person without gastric or GEJ adenocarcinoma who has or had a first degree relative eligible for a High Risk Genetic sub-group (EOGC/FGC).
  • Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease.
  • Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives.
  • A person without gastric or GEJ adenocarcinoma who has a personal family history of a genetic mutation associated with the development of gastric or GEJ adenocarcinoma (i.e. family history of CDH1 mutation).
  • II. Must be willing to provide a blood sample for germline DNA. These individuals will sign the "Patient/Relative Consent". Following enrollment, we will assign individuals to the appropriate High Genetic Risk or Low Genetic Risk groups based on the age of diagnosis and their family history.
  • Subject Exclusion Criteria
  • Patients are ineligible for the study if they:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Create registry of families w/ early onset & familial gastric cancer for analysis of risk factors, family history and unidentified susceptibility genes. Create cohorts of pts w/ low genetic risk for the development of gastric cancer

Time Frame: December 2010

Secondary Outcomes

  • To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.(December 2010)
  • To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.(December 2010)

Study Sites (10)

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