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Early Onset and Familial Gastric Cancer Registry


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

Early Onset and Familial Gastric Cancer Registry


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. 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

December 2010

Safety Issue:

No

Principal Investigator

David Kelsen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-118

NCT ID:

NCT00582257

Start Date:

December 2005

Completion Date:

December 2014

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • Stomach Cancer
  • 05-118
  • Stomach Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Queens Cancer Center of Queens HospitalJamaica, New York  11432
SUNY Downstate Medical CenterBrooklyn, New York  11203
Weill Cornell Medical CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at CommackCommack, New York  11725
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
University of Southern California - Norris Cancer HospitalLos Angeles, California  90033