Gastric Cancer
Conditions
Keywords
Gastric Cancer, Stomach Cancer, 05-118
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.
Interventions
BEHAVIORALquestionnaires
Participation in the registry will consist of adequately completing the family history questionnaire (one per family) the gastric cancer risk factor questionnaire and providing a blood sample for future correlative studies. Registry participants (both Patient/Relative and Control cohorts) will be required to submit tissue (both normal and/or tumor) to create a Tissue and DNA repository. Select participants will be invited to undergo Genetic Counseling, eg. those participants who meet clinical criteria for HDGC.
Sponsors
Weill Medical College of Cornell University
Queens Health Network
University of Southern California
Shaare Zedek Medical Center
Obafemi Awolowo University Teaching Hospital
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient/Relative Cohort: Must meet one or more criteria below: 1. A person with a diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed at the treating institution. 2. 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). 1. Early Onset Gastric Cancer - diagnosis of gastric cancer before the age of 50 without a family history of the disease. 2. Familial Gastric Cancer - having a family history of gastric cancer as defined as one first degree relative or 2 second degree relatives. 3. 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: * Have any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent. * Relatives of patients that are not eligible for the High Genetic Risk Cohorts who are less than 18 years of age are excluded. * Relatives of patients eligible for the High Genetic Risk Cohorts who do not have a proband available to join the study are excluded. (Unless there is a known CDH1 mutation in the family).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | December 2010 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Nigeria, United States
Outcome results
None listed