Early Onset and Familial Gastric Cancer Registry
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer, Stomach Cancer, 05-118
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: questionnaires
Type: Behavioral
Overall Status
Recruiting
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.
Detailed Description
On a global basis, cancer of the stomach is the third most prevalent malignancy, with 947,000 expected new cases in 2000, and the second leading cancer cause of death (734,000 deaths annually). In the United States in 2003, approximately 22,400 cases of gastric cancer will be diagnosed, and 12,100 patients will die from this disease1. The prognosis of this disease is poor with 5-year relative survival rate of less than 20% for advanced disease. The etiology of gastric cancer is attributable to both environmental and hereditary factors. In the subset of patients with early onset disease and in particular among familial forms of this disease, inherited susceptibility appears to play a dominant role. No single mutation has been identified as responsible for early onset gastric cancer. Recent evidence has emerged supporting the role of germline mutations in the E-cadherin gene (CDH1) as conferring increased susceptibility to early onset diffuse type gastric cancer and better understanding of other genes that predispose to gastric cancer tumorigenesis is anticipated in the next several years2, 3. The primary purpose of this protocol is to establish a prospective registry with detailed family history, gastric cancer risk factors, germline DNA, and matched tumor and normal tissue for patients with early onset or familial gastric cancer and their at-risk relatives. With this aim in mind, we have amended the registry to include populations who are at low risk for germline etiology for the development of gastric cancer. This includes a cohort of patients with gastric cancer who appear to have developed the disease sporadically, as well as a cohort of control patients without gastric cancer. Secondary objectives are 1) To measure the incidence of germline mutations in CDH1 among "early onset" and "familial" gastric cancer patients and their relatives to determine the importance of this variant in gastric cancer susceptibility and 2) To measure the prevalence of abnormal gastric pathology among the cancer-free relatives of patients with "early onset" and "familial" gastric cancer. In this research protocol, early onset gastric cancer (EOGC) is defined as disease with age of onset before 50 that arises in the absence of family history of gastric cancer or known hereditary cancer syndrome. Familial gastric cancer (FGC) is defined as disease that occurs among individuals with at least one affected first degree relative or two or more affected second degree relatives.Patients eligible for the "sporadic" cohort are those not eligible for the EOGC or FGC. We will also establish a "low risk" cohort for comparison. Patients eligible for the "low risk" cohort are those not eligible for the EOGC or FGC. Study participants will fill out a questionnaire on their family history and on their gastric cancer risk factors. Participants will be invited to provide a sample of germline DNA for future genetic studies. Select high risk individuals, for example those that meet criteria for Diffuse Hereditary Gastric Cancer(DHGC), will be invited to participate in genetic counseling which is required prior to evaluation for CDH1 gene mutations. Select MSKCC participants who have Hereditary Diffuse Gastric Cancer syndrome with identified CDH1 germline genetic mutation may be invited by MSKCC only to complete a Pre-implantation Genetic Diagnosis (PGD) survey. In addition, participants will be invited to provide tissue (tumor and normal) where available, both fresh frozen and paraffin-embedded if possible. At risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. At select sites, at risk relatives of patients with EOGC/FGC will also be invited for a single upper endoscopy screening test. The Early Onset/Familial Gastric Cancer Registry will serve as a source of clinical and pathological material that can be used to identify future genetic abnormalities that may or may not predispose the development of gastric cancer in these high-risk families and will help define a cohort for participation in future chemoprevention/screening studies. Moreover, it will ensure that there is a coherent unified approach for management of this rare group of patients.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.

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).

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.

Control Cohort

Must meet all criteria below:

1. Does not have gastric cancer.

2. Not a blood relative of patient or relative participants.

3. No family history of a mutation in the CDH1 gene.

These individuals will sign the "Control consent". Note: A participant's genetic risk group is subject to change due to change in their diagnosis, family history, or genetic test results.

Subject Exclusion Criteria

Patients are ineligible for the study if they:

- Have any condition, which in the opinion of the primary MSKCC 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).

- Control participants who are less than 18 years of age are excluded.
Locations
University of Southern California - Norris Cancer Hospital
Los Angeles, California, United States
Status: Recruiting
Contact: Heinz-Josef Lenz, MD - 323-865-3955
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: David Kelsen, MD - 212-639-8470
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Status: Recruiting
Contact: David Kelsen, MD - 212-639-8470
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States
Status: Recruiting
Contact: Margaret Kemeny, MD - 718-883-4031
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: David Kelsen, MD - 212-639-8470
Weill Cornell Medical Center
New York, New York, United States
Status: Recruiting
Contact: Manish A. Shah, MD - 646-962-6200
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: David Kelsen, MD - 212-639-8470
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: David Kelsen, MD - 212-639-8470
Sha'are Zedek Medical
Jerusalem, Israel
Status: Recruiting
Contact: Alberto Gabizon, MD - alberto@md.huji.ac.il
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Nigeria
Status: Suspended
Start Date
December 2005
Completion Date
December 2015
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page