Clinical trial NCT00582257: Early Onset and Familial Gastric Cancer Registry
Official title: Early Onset and Familial Gastric Cancer Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Stomach Cancer
05-118
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Queens Health Network
name: University of Southern California
name: Shaare Zedek Medical Center
name: Obafemi Awolowo University Teaching Hospital
First posted: 2007-12-28
Enrollment: 971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK or collaborating centers. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participation and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.

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.


Eligibility 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 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).

Primary outcomes:
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
timeFrame: December 2010
Secondary outcomes:
measure: To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.
timeFrame: December 2010
measure: To determine the gastric pathology evident from a single baseline endoscopic screen of unaffected first-degree relatives of a patient with EOGC or FGC.
timeFrame: December 2010
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California - Norris Cancer Hospital
state: California
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center at Commack
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center at Mercy Medical Center
state: New York
city: West Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospital
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Kelsen, MD
role: PRINCIPAL_INVESTIGATOR
References: