Early Onset and Familial Gastric Cancer Registry

Gastric Cancer Clinical Trial

Official title:

Early Onset and Familial Gastric Cancer Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00582257
• Other study ID #: 05-118
• Status: Active, not recruiting
• Start date: December 2005
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 971
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Behavioral:
• questionnaires
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.

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University Teaching Hospital	Ile-Ife
United States	Memorial Sloan Kettering Cancer Center at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center at Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	University of Southern California - Norris Cancer Hospital	Los Angeles	California
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center at Mercy Medical Center	Rockville Centre	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Obafemi Awolowo University Teaching Hospital, Queens Health Network, Shaare Zedek Medical Center, University of Southern California, Weill Medical College of Cornell University

Countries where clinical trial is conducted

United States,  Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the incidence of CDH1 germline mutations among individuals with early onset or familial gastric cancer and their relatives.		December 2010
Secondary	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

External Links

•   Memorial Sloan Kettering Cancer Center website